Recall Z-0711-2024 ยท FYA Gown, Surgical
MEDLINE INDUSTRIES, LP - Northfield
Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
| Date | Jan 11, 2024 (initiated Nov 29, 2023) |
| Status | Open, Classified |
| Reason | Surgical gowns were manufactured with the wrong sleeve. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 2,100 gowns |
| Distribution | Distribution was made to MD, OH, TN, TX, and WI. There was no government/military/foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182172 | Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora) Medline Industries, Inc., Apr 24, 2019 |