Uspack-suture KIT recall: Impurity Out of Spec
USPACK-SUTURE KIT; Item Number: US1672
Why was Uspack-suture KIT recalled?
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
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?
A5D0789X
- Product
- USPACK-SUTURE KIT; Item Number: US1672
- Recalling firm
- Medtronic
- Quantity
- 478,465 (total for all products)
- Distribution
- Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
- Recall date
- June 21, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)