FDAClass IIMay 7, 2014

CAPIO, Monodeck, Violet Monofilament Polydioxanone recall

CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code…

Why was CAPIO, Monodeck, Violet Monofilament Polydioxanone recalled?

The product did not meet minimum and/or average minimum Teleflex resorption 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: 833-137, Lot numbers: 02A0901938, 02B0901537, 02H1001025, 02H1001026, 02H1001027, 02C1102979, 02C1102983, 02D1300294, 02D1301164, 02C1302078, 02D1302468.

Product
CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code…
Recalling firm
Teleflex Medical
Quantity
7,380 ea (total)
Distribution
Worldwide Distribution - US Nationwide in the states of CA, CO, GA, LA, IL, MA, MI, MN, MO, NC, and in the countries of Ireland and Singapore.
Recall date
May 7, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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