Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate

FDA device recall Z-0004-2013 · posted 2012-10-02 · Terminated

Recall details

Recalling firm

Cure Medical LLC

Reason for recall

The firm initiated the product recall because labeling on some of the intermediate boxes of catheters identify the contents to be M16C, a coud-tip catheters while the actual contents are M16Fr male, 16Fr, straight-tip catheters with the pouch and the case box labeled as M16Fr male, 16Fr, straight-tip catheters.

Action taken

Cure Medical LLC sent an Urgent Medical Device Correction and Removal Notification letter dated September 19, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter instructed the customers to: a) Check their shelves for M16C with lot number 120425 and quarantine all affected product. b) Verify the contents (pouch label) are M16C and correspond with the intermediate box label. c) If all match, have the dealer sign and return a supplied verification record. d) If any mismatch is found, contact Cure Medical for assignment of a return goods authorization. e) Cure Medical will replace any incorrect product along with processing costs for this situation to the dealer. If affected product was further distributed customers were asked to identify those customers who received them and notify them of the problem. For questions customers were instructed to call 1-800-570-1778.

Root cause

Labeling mix-ups

Status

Terminated

Product code

EZD

Quantity affected

420cases (= 4,200 boxes)

Distribution

Nationwide Distribution

Date initiated

2012-09-19

Date posted

2012-10-02

Date terminated

2013-02-07

Location

Newport Beach, CA

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