Recall Z-1067-2023
MEDLINE INDUSTRIES, LP - Northfield · initiated November 17, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALVE PACK i. OPEN HEART CDS-3 j. OPEN HEART PACK k. OPEN HEART PACK l. OPEN HEART ADULT m. OPEN HEART CDS PART A n. GLENNON OPEN HEART CDS o. OPEN HEART CDS p. MEMORIAL MED CTR BYPASS q. OPEN HEART PEDS r. OPEN HEART CDS-4 s. OPEN HEART t. CAB CDS u. VASCULAR CDS v. VALVE CDS w. OPEN HEART PACK-LF x. VASCULAR CDS-LF y. OPEN HEART B CDS-LF z. CRANIOTOMY CDS aa. OPEN UROLOGY CDS-LF bb. TOTAL KNEE CDS cc. LOWER EXTREMITY CDS-LF dd. LAMINECTOMY CDS ee. ENDOVASCULAR CDS ff. VASCULAR gg. VASCULAR CDS-3 hh. VASCULAR ACCESS CDS ii. ZALE PUMP CDS jj. CUH ENDOVASCULAR CDS kk. CUH MINOR VASCULAR CDS ll. FHT CVOR CABG mm. OPEN HEART CDS nn. OPEN HEART CDS oo. CAROTID ENDARTERECTOMY CDS-LF pp. PACER CDS qq. PERIPHERAL VASCULAR CDS rr. ACH OPEN HEART ss. ACH OPEN HEART tt. OPEN HEART CDS uu. VASCULAR CDS vv. CV CDS ww. OPEN HEART CABG PACK-LF xx. MAJOR VASCULAR PACK-LF yy. CARDIOVASCULAR PACK-LF zz. VASCULAR HARPER PACK-LF aaa. CABG 1 OR 2 HARPER PACK bbb. TAVR 1 PACK-LF ccc. ENDO VASCULAR PACK-LF ddd. OPEN HEART A & B PACK eee. PACEMAKER IMPLANT PACK-LF fff. PERIPHERAL VASCULAR PACK-LF ggg. PACEMAKER PACK-LF hhh. RR-NEURO VASCULAR PACK-LF iii. CARDIAC CHEST PACK 80701 jjj. OPEN HEART PACK-LF kkk. PACEMAKER PACK-LF lll. CARDIOVASCULAR PACK-LF mmm. OPEN HEART PACK A & B nnn. MINOR VASCULAR PACK ooo. OPEN HEART PACK-LF ppp. SMALL VASCULAR PACK-LF qqq. MAJOR VASCULAR PACK-LF rrr. PEDIATRIC CARDIAC PACK-LF sss. OH VALVE PACK-LF ttt. HEART OVERHEAD TABLE PACK uuu. OPEN HEART PACK vvv. PACEMAKER PACK-LF www. VASCULAR PACK-LF xxx. OPEN HEART PACK yyy. VASCULAR PACK zzz. CV BASIC SET UP PACK aaaa. UNIVERSAL OPEN HEART PACK bbbb. VASCULAR BYPASS PACK-LF cccc. BMC CABG PACK A dddd. CUSTOM CAROTID eeee. A-V FISTULA PACK-LF ffff. PERIPHERAL VASCULAR PACK-LF gggg. ECMO PACK hhhh. HEART PACK iiii. CABG PACK A&B jjjj. OPEN HEART PACK kkkk. CV A & B llll. PEDIATRIC OPEN HEART-NS-LF mmmm. PACEMAKER NORTH nnnn. OPEN HEART PACK oooo. SVMMC CORE OPEN HEART PACK-LF pppp. PACEMAKER TRAY-LF qqqq. PACEMAKER PACK rrrr. MAJOR VASCULAR-RF-LF ssss. AV FISTULA-LF tttt. PACEMAKER PACK uuuu. VASCULAR PACK vvvv. PACEMAKER wwww. MAJOR VASCULAR PACK xxxx. MAJOR VASCULAR PACK yyyy. VASCULAR PACK zzzz. PACEMAKER PACK-LF aaaaa. RRMC CABG AUXILIARY TRAY bbbbb. RRMC OPEN HEART PACK ccccc. MAJOR VASCULAR PACK ddddd. PACEMAKER PACK eeeee. PACEMAKER TRAY fffff. PACEMAKER PACK ggggg. PACEMAKER PACK hhhhh. AV FISTULA PK-LF iiiii. FHT PACER PACK jjjjj. PACEMAKER SET UP PACK kkkkk. MAJOR VASCULAR PACK lllll. PACEMAKER PACK-LF mmmmm. CAROTID PACK nnnnn. MAJOR VASCULAR PACK ooooo. VASCULAR PACK GH-LF ppppp. A-V FISTULA PACK GH-LF qqqqq. VASCULAR PACK MH-LF rrrrr. PACEMAKER PACK L J sssss. OPEN HEART ttttt. OPEN HEART SUPPLY TRAY uuuuu. PACEMAKER PACK vvvvv. PACEMAKER PACK wwwww. VASCULAR PACK xxxxx. BASIC OPEN HEART PACK A B yyyyy. VASCULAR PACK zzzzz. OPEN HEART TRAY A-LF aaaaaa. VASCULAR PACK bbbbbb. PACEMAKER PACK cccccc. OPEN HEART PACK dddddd. ENDOVASCULAR PACK-LF eeeeee. VASCULAR PACK-LF ffffff. BASIC OPEN HEART PACK-LF gggggg. OPEN VASCULAR PACK-LF hhhhhh. PK, EP LAB PACEMAKER iiiiii. PK, OPEN HEART-CABG jjjjjj. OPEN HEART PACK kkkkkk. PK, OPEN HEART- A&B llllll. SVMMC VASCULAR MAJOR PACK mmmmmm. CV PACK nnnnnn. OPEN HEART PACK A AND B oooooo. SVMMC CAROTID PACK pppppp. PK, OPEN HEART-CABG A&B qqqqqq. PK, OPEN HEART-A&B rrrrrr. VASCULAR PACK ssssss. PK, OPEN HEART tttttt. PK, OPEN HEART uuuuuu. OPEN HEART PACK vvvvvv. PK, OPEN HEART-A&B wwwwww. OPEN HEART PACK xxxxxx. PK, OPEN HEART-CABG yyyyyy. PK, OPEN HEART zzzzzz. CASTRO CABG-COMPONENT PACK aaaaaaa. RE-ENTRY PACK bbbbbbb. HEART PACK ccccccc. OPEN HEART SUPPLY PACK ddddddd. PK, OPEN HEART-CABG eeeeeee. CABG PROCEDURE PACK fffffff. CABG PACK ggggggg. PK, OPEN HEART hhhhhhh. VASCULAR GRAFT PACK iiiiiii. PK, OPEN HEART jjjjjjj. VASCULAR PACK kkkkkkk. PK,
Codes / lots: a. EP LAB PACEMAKER PACK, Item Number: 00-401893L, Case UDI/GTIN: 40195327127887, Unit UDI/GTIN: 10195327127886, Lot Number: 22JMC769; b. OPEN HEART CDS, Item Number: CDS840016AD, Case UDI/GTIN: 40193489741842, Unit UDI/GTIN: 10193489741841, Lot Number: 22KBB889; c. OPEN HEART CDS, Item Number: CDS840023T, Case UDI/GTIN: 40193489682060, Unit UDI/GTIN: 10193489682069, Lot Number: 22JBU353,22JBT770; d. AAA CDS, Item Number: CDS840076AC, Case UDI/GTIN: 40195327209620, Unit UDI/GTIN: 10195327209629, Lot Number: 22KBE518; e. OPEN HEART CDS, Item Number: CDS840094N, Case UDI/GTIN: 40195327089512, Unit UDI/GTIN: 10195327089511, Lot Number: 22JBI258,22IBF817; f. PACEMAKER CDS, Item Number: CDS840162V, Case UDI/GTIN: 40193489480628, Unit UDI/GTIN: 10193489480627, Lot Number: 22KBG388,22IBP339; g. HEART CDS, Item Number: CDS840179M, Case UDI/GTIN: 40889942894001, Unit UDI/GTIN: 10889942894000, Lot Number: 22JBJ710,22IBQ944; h. VALVE PACK, Item Number: CDS840187T, Case UDI/GTIN: 40193489816465, Unit UDI/GTIN: 10193489816464, Lot Number: 22JMG653; i. OPEN HEART CDS-3, Item Number: CDS840246N, Case UDI/GTIN: 40889942217428, Unit UDI/GTIN: 10889942217427, Lot Number:…
Reason for recall
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
FDA-determined cause: Device Design
Action taken
Medline Industries, LP notified consignees via email and first-class mail on 11/15/2022. Consignees were instructed to check stock for affected product and immediately quarantine. For any affected units, customers were instructed to over-label the sterile kits with a warning label indicating "Warning To Avoid Injury, Please Handle Blades with Care." No product is to be returned. Customers were also instructed to complete and return the response form and notify customers if further distributed.
Details
- Recall number
- Z-1067-2023
- Initiated
- November 17, 2022
- Posted by FDA
- February 6, 2023
- Product code
- OEZ – Cardiovascular Procedure Kit
- Quantity
- 12,964 cases (23,379 units)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1060-2023 Class II | ANCILLARY PACK-LF. Sterile Procedural Tray.Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1061-2023 Class II | TRACH PACK. Sterile Procedural Tray.Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1062-2023 Class II | LOCAL PACK. Sterile Procedural Tray.Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1063-2023 Class II | Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASICSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1064-2023 Class II | UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural TraySterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1065-2023 Class II | FEMORAL ARTERY PACK-LF. Sterile Procedural TraySterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1066-2023 Class II | Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b.…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1068-2023 Class II | Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b.…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1069-2023 Class II | Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1070-2023 Class II | Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b.…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1071-2023 Class II | Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1072-2023 Class II | Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1073-2023 Class II | Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1074-2023 Class II | Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1075-2023 Class II | Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPYSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1076-2023 Class II | Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDOSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1077-2023 Class II | Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1078-2023 Class II | Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b.…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1079-2023 Class II | Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1080-2023 Class II | Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b. KNEE…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1081-2023 Class II | Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACKSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1082-2023 Class II | Sterile Procedural Trays, labeled as the following: IM NAILSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1083-2023 Class II | Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c.…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1084-2023 Class II | Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LFSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1085-2023 Class II | Sterile Procedural Trays, labeled as the following: LS MS PACKSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1086-2023 Class II | Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACKSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1087-2023 Class II | Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACKSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1088-2023 Class II | Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1089-2023 Class II | Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b.…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |
| Z-1090-2023 Class II | Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPYSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… | 11/17/2022Open, Classified |