Sutures. Endo Stitch: Endo Stitch Polysorb 0 48" U/d recall: Impurity Out of Spec
Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO…
Why was Sutures. Endo Stitch: Endo Stitch Polysorb 0 48" U/d 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?
ENDO STITCH* POLYSORB* 0 48" U/D DLU SU J4M0853X J4M0855X J5A0192X ENDO STITCH* POLYSORB* 0 48" VIO DLU SU J4L1477X ENDO STITCH*POLYSORB* 2/0 48" U/D DLU SU J5A1097X ENDO STITCH*POLYSORB* 2/0 48" VIO DLU SU J5A0702X J5A0703X J5A0704X J5A0705X J5A1206X J5A1207X
- Product
- Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO…
- 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)