GEM Coupler Forceps recall
GEM Coupler Forceps, GEM4183C, packaged individually.
Why was GEM Coupler Forceps recalled?
Potential presence of rust on Coupler Forceps (GEM4183C).
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?
Product Code 5193-06001-010, Lot Number: SP18E129-1307852, Sub-lot Number: 90828, UDI: 00844735002850
- Product
- GEM Coupler Forceps, GEM4183C, packaged individually.
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 123 devices
- Distribution
- Nationwide distribution to CA, FL, GA, KS, LA, MA, MS, NE, NJ, NV, NY, OH, PA, TX, UT, VA, WA, WV. International distribution to United Kingdom, Germany, South Africa, Japan, and Australia
- Recall date
- January 2, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)