FDAClass IIJuly 31, 2013

Rultract Retractor Ratchet Cover Plate recall

Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site

Why was Rultract Retractor Ratchet Cover Plate recalled?

The firm became aware of the problem when a ratchet cover plate on a device was returned for repair showed signs of corrosion.

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?

M/N 4100-IMR-6: S/N's: 4829-4839, 4845-4851, 4857-4871, 4874-4884, 4894-4908 & 4916-4923; M/N 4100-IMR-41: S/N's: 4840-4844, 4852-4856, 4888-4893, 4913-4915 & 4926-4927.

Product
Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site
Recalling firm
Pemco Inc
Quantity
87 units
Distribution
Worldwide Distribution - USA including AL, CA, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NJ, NM, NV, OK, PA, TN, TX, UT, VA & WA. Internationally to Czech Republic, Italy, Japan, Korea & Singapore.
Recall date
July 31, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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