Recall Z-1068-2023
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. PORT/TRACH INSERTION CDS-3 b. RESIDENT DERM SURG PACK c. THROMBECTOMY PACK-LF d. AV FISTULA PACK e. AV SHUNT PACK-LF f. RR-VP SHUNT PACK-LF g. VEIN HARVESTING PACK-LF h. AV FISTULA PACK-LF i. PK, GEN-BARIATRIC j. VEIN PACK k. VENOUS ACCESS PACK-LF l. VENOUS ACCESS PACK m. VASCULAR ACCESS PACK n. ARTERIOGRAM PACK o. AV FISTULA/GRAFT INSER PK p. VEIN ABLATION PACK q. PORT PACK r. MINOR VASCULAR s. FISTULA PACK t. AV FISTULA-LF u. AV FISTULA v. PORT VENOUS ACCESS w. AV FISTULA
Codes / lots: a. PORT/TRACH INSERTION CDS-3, Item Number: CDS983004D, Case UDI/GTIN: 40889942000464, Unit UDI/GTIN: 10889942000463, Lot Number: 22IBF922,22IBE764; b. RESIDENT DERM SURG PACK, Item Number: DYNDA2997, Case UDI/GTIN: 40195327235353, Unit UDI/GTIN: 10195327235352, Lot Number: 22JBR611; c. THROMBECTOMY PACK-LF, Item Number: DYNJ0160348B, Case UDI/GTIN: 40889942211594, Unit UDI/GTIN: 10889942211593, Lot Number: 22IDB621; d. AV FISTULA PACK, Item Number: DYNJ01966N, Case UDI/GTIN: 40193489383769, Unit UDI/GTIN: 10193489383768, Lot Number: 22IMA429; e. AV SHUNT PACK-LF, Item Number: DYNJ0781844W, Case UDI/GTIN: 40193489226530, Unit UDI/GTIN: 10193489226539, Lot Number: 22IMG652; f. RR-VP SHUNT PACK-LF, Item Number: DYNJ0785917M, Case UDI/GTIN: 40193489412827, Unit UDI/GTIN: 10193489412826, Lot Number: 22GMH382; g. VEIN HARVESTING PACK-LF, Item Number: DYNJ0826732I, Case UDI/GTIN: 40193489377973, Unit UDI/GTIN: 10193489377972, Lot Number: 22IMF839; h. AV FISTULA PACK-LF, Item Number: DYNJ0826753O, Case UDI/GTIN: 40193489384292, Unit UDI/GTIN: 10193489384291, Lot Number: 22JMH548,22IMC908; i. PK, GEN-BARIATRIC, Item Number: DYNJ33890B, Case UDI/GTIN: 40193489213455, Unit UDI/GTIN:…
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-1068-2023
- Initiated
- November 17, 2022
- Posted by FDA
- February 6, 2023
- Product code
- OFF – Central Venous Catheter Tray
- Quantity
- 622 cases (1,619 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-1067-2023 Class II | Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN…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 |