Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4… recallZ-0711-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated Nov 29, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Surgical gowns were manufactured with the wrong sleeve.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0711-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 29, 2023
- Posted by the FDA
- Jan 11, 2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 2,100 gowns
- Product code
- FYA
- FDA submissions
- K182172
- Distribution
- Distribution was made to MD, OH, TN, TX, and WI. There was no government/military/foreign distribution.
Product description
Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
Code information (models, lots, serial numbers)
Lot #11023060120, UDI (01)40080196029755(11)230615(10)11023060120.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline SPT-2208CSMedline Industries, Inc. · GOWN, SURGICAL1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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