Device product

Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).

Z-2231-2021

July 01, 2021

Class II

Product summary

Firm: Medline Industries Inc
Event: Event 88268
Status: Terminated
Classification: Class II
Quantity: 286 kits total for all products
Official record key: device-enforcement:Z-2231-2021

Official wording

Reason: The kits may contain an expired component.

Code information: REF DYNJ902837D - Lot 19IBE968, exp. 2020-09-30, GTIN (01)10193489720549; and REF DYNJ902837F - Lot 20LBU450, Exp. 2021-07-31, GTIN (01)10193489357233.

Distribution pattern: US Nationwide distribution in the states of MN, NE, and PA.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The kits may contain an expired component.