Dressing Shldr, P/N 04908 Product Usage: These products are sterile dressings used as an insulation barrier between the

FDA device recall Z-1905-2017 · posted 2017-05-02 · Terminated

Recall details

Recalling firm

Breg Inc

Reason for recall

They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.

Action taken

Breg sent an Urgent Medical Device Correction Letter to customers on 4/13/17. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: Please take the following actions: 1) Determine if any potentially affected products are in your stock by comparing each product's Lot and Date to the Lot Numbers and Expiration Dates in the table above. Refer to Picture 2 for the location of these fields on the product packaging. 2) Once you have matched Lot and Date, inspect the product to identify any open (unsealed) pouches. Refer to Picture 1 below. 3) Remove any open pouches from your inventory and discard. 4) Complete the Response Form included as Attachment A, and email or fax to Breg as follows: a. E-mail: bregfieldcorrection@breg.com: Subject: Sterile Dressing Correction b. Fax: 800-FAX-BREG (329-2734)- Subject: Sterile Dressing Correction Customers with questions are instructed to contact Breg Customer Care at (800) 321-0607.

Root cause

Employee error

Status

Terminated

Product code

KGX

Quantity affected

2,609 units total

Distribution

US Nationwide Distribution

Date initiated

2017-03-30

Date posted

2017-05-02

Date terminated

2017-06-23

Location

Carlsbad, CA