Irrigation Kit, Small, Vinyl, REF: 6116, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. Intended use: K

FDA device recall Z-1040-2011 · posted 2011-02-03 · Terminated

Recall details

Recalling firm

Apogee Medical

Reason for recall

This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products of Sterile Lubricating Jelly manufactured by Triad Group.

Action taken

The firm, TRIAD Group, sent a "Urgent Medical Device Recall" letter dated January 18, 2010 to all consignees/customers. The letter described the product, problem and the action to be taken by the customers. The customers were instructed to review there inventory, cease distribution of the affected lots and to complete and return the enclosed Product Recall Response Form via fax to 1-919-570-9611 or e-mail to Apogee Medical. If they distributed the product, they were instructed to notify their customers of the recall; to include a copy of the recall notification, and to instruct them to return the recalled product to the wholesaler who would then return the product to Apogee Medical. Non-responders to the recall notice will be contacted on a weekly basis. Should you have any questions regarding this notification, please call the Regulatory Affairs/Quality Assurance Manager at (919) 435-5409.

Root cause

Other

Status

Terminated

Product code

KMJ

Quantity affected

see line 1.

Distribution

Nationwide Distribution: USA including states of: AL, AZ, CA, FL, GA, IL, IN, KS, LA, MA, MO, NC, NJ, NY, OH, OK, PA, TN, TX, VA and WA.

Date initiated

2011-01-18

Date posted

2011-02-03

Date terminated

2012-02-28

Location

Youngsville, NC