FDAClass IMarch 5, 2014

Sterile Sample Cath LAB Pack recall

STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit…

Why was Sterile Sample Cath LAB Pack recalled?

Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.

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?

Pack Number: SAMP0213; Lot: 13CD1774

Product
STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit…
Recalling firm
Medline Industries, Inc.
Quantity
10 units
Distribution
Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.
Recall date
March 5, 2014
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls