USPACK-SUTURE KIT; Item Number: US1672
This recall has been terminated (originally issued May 3, 2017).
- Company
- Medtronic
- Recall Initiated
- May 3, 2017
- Terminated
- July 18, 2019
- Recall Number
- Z-2546-2017
- Quantity
- 478,465 (total for all products)
- Firm Location
- North Haven, CT
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
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.
Lot / Code Info
A5D0789X
Root Cause
Process control
Action Taken
All consignees were notified via Federal Express or certified mail on May 3, 2017, and the letter informs customers of the potential for an incomplete seal on the inner package and the actions they should take. Customers are requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice.
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