FDAClass IIApril 2, 2014

Sutures recall

Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage: Non-absorbable poly(ethylene terephthalate) surgical suture is a…

Why was Sutures recalled?

The products are being recalled because they did not meet minimum needle attachment strength requirements.

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?

Product Code: 0100019-507, Lot number: 02F1301128; Product Code: 6-511, Lot number: 02M0800561; Product Code: 6-559, Lot number: 02A0800005; Product Code: 69-403, Lot number: 02H0802530; Product Code: 7-5008M4, Lot number: 02C0900466; Product Code: 7-518, Lot number: 02E1302561; Product Code: 7-565, Lot number: 02B1100185; Product Code: 7-655A, Lot numbers: 02C0901963 & 02M0800836; Product Code: 7-740, Lot number: 02L1000536; Product Code: 833-114, Lot numbers: 02A1202112, 02C0903374 & 02D1202794; Product Code: 02F0902697, 02K1100404, 02L1202369 & 02M0802509; Product Code: E13-6351, Lot number: 02F0902446; Product Code: E13-6354, Lot number: 02F0902439; Product Code: E13-6399, Lot number: 02F0902436; Product Code: E6-545, Lot number: 02F0902443; Product Code: E7-4578, ot number: 02D0901672; Product Code: H5300, Lot number: 1450153E13; Product Code: RN6-5106M5, Lot number: 02F1003837; Product Code: RN7-536M5, Lot number: 02A0801205; Product Code: TEV100, Lot number: 02G1101500; Product Code: V-2599, Lot number: 02F0802055; Product Code: X-5424, Lot number: 02B0900765; Product Code: X6-692W, Lot number: 02C0803135; Product Code: X7-655M6A, Lot number: 02A0900806, 02A0902742, 02C0900446 & 02H1003233 and Product Code: XF7-7011, Lot numbers: 02A0901594.

Product
Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage: Non-absorbable poly(ethylene terephthalate) surgical suture is a…
Recalling firm
Teleflex Medical
Quantity
Total 32,271 ea.
Distribution
Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
Recall date
April 2, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls