FDAClass IIMarch 12, 2014

DeRoyal ST. Circumcision Clamp recall

DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.

Why was DeRoyal ST. Circumcision Clamp recalled?

Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely.

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?

lot numbers 33347799, 33444071, and 33423747

Product
DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
Recalling firm
DeRoyal Industries Inc
Quantity
2504 units
Distribution
US Distribution to states of: NJ, AL, TX, WA, IL, OK, VA, FL, OR, and KS.
Recall date
March 12, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls