Recalls / —
—#188255
Product
Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
- FDA product code
- OJH — Orthopedic Tray
- Device class
- Class 1
- Medical specialty
- General, Plastic Surgery
- Affected lot / code info
- REF DYNJ902837D - Lot 19IBE968, exp. 2020-09-30, GTIN (01)10193489720549; and REF DYNJ902837F - Lot 20LBU450, Exp. 2021-07-31, GTIN (01)10193489357233.
Why it was recalled
The kits may contain an expired component.
Root cause (FDA determination)
Employee error
Action the firm took
Consignees were notified by letter dated and issued on 7/1/2021 via first class mail. The letter informed the consignee the convenience kits were being recalled due to the irrigation bag expiring August 21,2020. The consignee was to immediately check their stock for the affected kit and kit lot number and affix the enclosed sticker on the kit which instructs the consignee to remove the expired irrigation bag and replace it with sterile product from their supply. The remainder of the components may be used.
Recalling firm
- Firm
- Medline Industries Inc
- Address
- 3 Lakes Dr, Northfield, Illinois 60093-2753
Distribution
- Distribution pattern
- US Nationwide distribution in the states of MN, NE, and PA.
Timeline
- Recall initiated
- 2021-07-01
- Terminated
- 2023-03-02
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #188255. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.