Ams, Aligned Medical Solutions, T&a Pack, Ams6357 recall: Sterility Concern
AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
Why was Ams, Aligned Medical Solutions, T&a Pack, Ams6357 recalled?
Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential sterile barrier breach.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Lot # 109138
- Product
- AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 60 kits
- Distribution
- US Distribution to the state of : SC
- Recall date
- November 15, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)