Lubricating Jelly, Sterile, Non-staining, Made in the USA, packaged into the following size containers 5 gram tube, 2 ou

FDA device recall Z-0934-2011 · posted 2011-01-21 · Terminated

Recall details

Recalling firm

H & P Industries, Inc. dba Triad Group

Reason for recall

Triad Group is recalling all lots of Sterile Lubricating Jelly manufactured by Triad Group. 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.

Action taken

The firm, Triad Group, sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 22, 2010, to all customers via US Postal Service certified. The letter described the issue, identified affected product as that which contained a lot number beginning with the digits 7, 8, 9, or 0, and the action to be taken by the customers. The customers were instructed to immediately examine their inventory and quarantine the product subject to recall; notify their customers at once if the recalled product was further distributed, and complete and return the enclosed Recall Acknowledgement form via fax at 262-538-2947 or mail along with the recalled product to: Recall Coordinator, Triad Group, 700 West North Shore Drive, Hartland, WI 53029. If you have any questions, please call Triad Group Customer Service Monday thru Friday, between the hours of 8:30 a.m. and 4:00 p.m. Central Time at 262-538-2900 ext 2761.

Root cause

Process control

Status

Terminated

Product code

KMJ

Quantity affected

453,787 cases

Distribution

Worldwide distribution: USA including states of: CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MI, MO, MS, MY, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI and Puerto Rico; and cou

Date initiated

2010-12-23

Date posted

2011-01-21

Date terminated

2012-06-11

Location

Hartland, WI

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