Upper Extremity PK recall
UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AG
Why was Upper Extremity PK recalled?
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI:00191072207791 LOT#"s: 658231 953241 899241
- Product
- UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AG
- Recalling firm
- American Contract Systems Inc
- Quantity
- 192 units
- Distribution
- US Nationwide distribution.
- Recall date
- July 17, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)