FDAClass IIDecember 25, 2013

Integra Disposable recall

Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR…

Why was Integra Disposable recalled?

Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the LOR syringes indicating the plunger of the syringe may stall or stick when travelling within the syringe.

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?

Kit Cat No: 10-2433,13-2595,13-2616,13-2628,3104195,3403061,3403150,3403316,3403579,3403727,3403776,3403813,3403989,3404131,3404269,3404293,3404417,3404468,3404578,3503559,CUS025,CUS1121-01,CUS1164-02,CUS1202-04,CUS1298-03,CUS1376,CUS1376,CUS1400-01,CUS1406-03,CUS1415-04,CUS1568-01,CUS1664-01,CUS1696,CUS1723,CUS1760,CUS1773-01,CUS1797,CUS279-02,CUS416,CUS597,CUS628-02,CUS755,PISLL7,RSM394,RSM395,SS1246,SS2036-01,

Product
Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR…
Recalling firm
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Quantity
359,250
Distribution
USA Nationwide Distribution and one foreign consignee in Mursalat.
Recall date
December 25, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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