Medline Custom Sterile Surgical Packs which contain a Tyvek Breather Pouch, part number 32901, lot numbers 44134-01 and

FDA device recall Z-0554-05 · posted 2005-03-11 · Terminated

Recall details

Recalling firm

Medline Industries, Inc.

Reason for recall

There is a potential for open side seals post-sterilization of the Tyvek breather pouches used in the custom sterile packs.

Action taken

Field Correction letters dated 3/4/05 were sent to thedirect account hospitals on the same date to the attention of the manager of surgery, informing them of the potential indadequate side seal of the Tyvek breather pouches in the packs which may cause a compromise in the sterility of the product. The accounts were provided a list of the affected pack sent to the account and were requested to inspect any stocks of the affected product in stock, using the enclosed diagrams as an aid in the inspection for the defective side seals. Any defective product found should be returned to Medline. Any questions were directed to Lara Simmons, QA/RA Director at 1-800-879-2781, ext. 6072.

Root cause

Other

Status

Terminated

Product code

LRO

Quantity affected

31,497 cases

Distribution

Nationwide

Date initiated

2005-03-04

Date posted

2005-03-11

Date terminated

2006-05-25

Location

Waukegan, IL