FDAClass IIMay 22, 2013

Absorbable Collagen Sponge Provided As Intermediate to recall

Absorbable Collagen Sponge Provided As Intermediate to Another Company

Why was Absorbable Collagen Sponge Provided As Intermediate to recalled?

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

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?

1130055, 1130057, 1130228, 1130229, 1130388, 1105192, 1110821, 1110822, 1110987, 1111023, 1112020, 1112379, 1104815, 1110841, 1110842, 1110843, 1110953, 1110954, 1111022, 1111821, 1105206, 1110844, 1110903, 1110904, 1110931, 1110932, 1112021, 1104791, 1104961, 1105174, 1105453, 1105454, 1110826, 1110827, 1110969, 1111159, 1111160, 1104710, 1110828, 1111158, 1111764

Product
Absorbable Collagen Sponge Provided As Intermediate to Another Company
Recalling firm
Integra LifeSciences Corporation
Quantity
84,460 boxes
Distribution
Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
Recall date
May 22, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls