Recall Z-1097-2023
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. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY CDS c. ARTHROSCOPY LV - EDOC PACK-LF d. ARTHROSCOPY PACK-LF e. ARTHROSCOPY PACK f. ARTHRO PACK-LF g. ARTHROSCOPY PACK-LF h. ARTHROSCOPY PACK-LF i. ARTHROSCOPY KNEE TRAY-LF j. ARTHROSCOPY PACK-LF k. ARTHROSCOPY BASIN PACK-LF l. ARTHROTOMY PACK-LF m. ARTHROSCOPY PACK-LF n. ARTHROSCOPY PACK o. ARTHROSCOPY PACK p. ARTHROSCOPY PACK q. ARTHROSCOPY PACK - LF r. SC ARTHROSCOPY PACK s. ARTHROSCOPY PACK-LF t. ARTHROSCOPY PACK u. ARTHROSCOPY PACK v. ARTHROSCOPY PACK w. OSC ARTHROSCOPY PK-LF x. ARTHROSCOPY PACK y. ARTHROSCOPY PACK z. ARTHROSCOPY PACK aa. ARTHROSCOPY PACK bb. ARTHROSCOPY PACK cc. KNEE ARTHROSCOPY PACK dd. KNEE ARTHROSCOPY PACK ee. SHOULDER ARTHROSCOPY PACK ff. SHOULDER ARTHROSCOPY gg. ARTHROSCOPY PACK hh. ARTHROSCOPY PACK ii. ARTHROSCOPY PACK jj. ARTHROSCOPY PACK kk. ARTHROSCOPY PACK ll. ARTHROSCOPY PACK-LF mm. ARTHROSCOPY KNEE nn. ARTHROSCOPY PACK oo. HIP ARTHROSCOPY PACK pp. ARTHROSCOPY PACK qq. MG NS KNEE ARTHROSCOPY PACK rr. KNEE ARTHROSCOPY PACK ss. ARTHROSCOPY PACK tt. ARTHROSCOPY-LF uu. ARTHROSCOPY KIT vv. SHOULDER ARTHROSCOPY ww. KNEE ARTHROSCOPY xx. ARTHROSCOPY PACK
Codes / lots: a. KNEE ARTHROSCOPY CDS-LF, Item Number: CDS940869U, Case UDI/GTIN: 40195327210046, Unit UDI/GTIN: 10195327210045, Lot Number: 22JBR468,22JBA443; b. ARTHROSCOPY CDS, Item Number: CDS985208B, Case UDI/GTIN: 40889942942061, Unit UDI/GTIN: 10889942942060, Lot Number: 22JBR379,22IBS410,22IBO331,22IBO332; c. ARTHROSCOPY LV - EDOC PACK-LF, Item Number: DYNJ0111409L, Case UDI/GTIN: 40889942824015, Unit UDI/GTIN: 10889942824014, Lot Number: 22JMH535,22IMF440; d. ARTHROSCOPY PACK-LF, Item Number: DYNJ0376528J, Case UDI/GTIN: 40889942395935, Unit UDI/GTIN: 10889942395934, Lot Number: 22JBJ567; e. ARTHROSCOPY PACK, Item Number: DYNJ04446N, Case UDI/GTIN: 40888277753649, Unit UDI/GTIN: 10888277753648, Lot Number: 22JMH875,22HMG756; f. ARTHRO PACK-LF, Item Number: DYNJ0637509B, Case UDI/GTIN: 40889942079255, Unit UDI/GTIN: 10889942079254, Lot Number: 22IMH393; g. ARTHROSCOPY PACK-LF, Item Number: DYNJ0751097M, Case UDI/GTIN: 40195327196364, Unit UDI/GTIN: 10195327196363, Lot Number: 22HMC138; h. ARTHROSCOPY PACK-LF, Item Number: DYNJ0890114F, Case UDI/GTIN: 40889942824039, Unit UDI/GTIN: 10889942824038, Lot Number: 22JMC992,22IMG334; i. ARTHROSCOPY KNEE TRAY-LF, Item Number: DYNJ09577J, Case…
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-1097-2023
- Initiated
- November 17, 2022
- Posted by FDA
- February 6, 2023
- Product code
- OII – Arthrogram Tray
- Quantity
- 1,419 cases (4,349 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-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 |