Device product

Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B.

Z-1646-2023

April 21, 2023

Class II

Product summary

Firm: MEDLINE INDUSTRIES, LP - Northfield
Event: Event 92204
Status: Ongoing
Classification: Class II
Quantity: 342 packs (114 packs/product)
Official record key: device-enforcement:Z-1646-2023

Official wording

Reason: The kits were damaged by water.

Code information: (1) Arthroscopy Pack - Lot #22HMD098, Exp. 2024-04-30, UDI/DI (01)10193489956405; (2) Shoulder Pack -Lot #22JMA673, Exp. 2024-01-31, GTIN (01)10193489429817; and (3) Upper Extremity Pack - Lot #HMF900, Exp. 2024-01-31, UDI/DI (01)10193489968453.

Distribution pattern: Distribution was made to California. There was no foreign/government/military distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The kits were damaged by water.