Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
This recall is currently active, issued January 11, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- November 29, 2023
- Posted
- January 11, 2024
- Recall Number
- Z-0711-2024
- Quantity
- 2,100 gowns
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Surgical gowns were manufactured with the wrong sleeve.
Distribution
Distribution was made to MD, OH, TN, TX, and WI. There was no government/military/foreign distribution.
Lot / Code Info
Lot #11023060120, UDI (01)40080196029755(11)230615(10)11023060120.
Root Cause
Process control
Action Taken
The recalling firm issued letters dated 11/29/2023 via email and first class mail on 11/29/2023. The letter explained the reason for recall and provided required actions. Those actions were to (1) Immediately check the stock for the affected item and lot numbers which can be located within the recall portal; (2) Use the link and information in the letter to complete the response form; and (3) Destroy any affected inventory and the recalling firm will issue a credit. If the consignee is a distributor or has resold or transferred the product to another company or individual, the consignee is to notify the downstream company.