Recalls / —

—#204798

Product

Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.

FDA product code

FYA — Gown, Surgical

Device class

Class 2

Medical specialty

General, Plastic Surgery

510(k) numbers

K182172

Affected lot / code info

Lot #11023060120, UDI (01)40080196029755(11)230615(10)11023060120.

Why it was recalled

Surgical gowns were manufactured with the wrong sleeve.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

MEDLINE INDUSTRIES, LP Northfield

Address

3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern

Distribution was made to MD, OH, TN, TX, and WI. There was no government/military/foreign distribution.

Timeline

Recall initiated

2023-11-29

Posted by FDA

2024-01-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #204798. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.