| ||Class 2 Recall|
Sterile Lubricating Jelly
||January 21, 2011
||Lubricating Jelly, Sterile, Non-staining, Made in the USA, packaged into the following size containers 5 gram tube, 2 ounce and 4 ounce tubes, 4 ounce bottle, 3 and 5 gram packets
Intended use: A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
1. Allegiance, Distributed by: Cardinal Health, McGaw Park, IL 60085-6787, USA, Cat. LJT2. Net Wt. 2 oz., Cat. LJF3, Net Wt. 3g, Cat. LJT4, Net Wt. 4 oz., Cat. LJT5, Net Wt. 5 g;
2. Select medical products, manufactured for PSS World Medical, Inc., 4345 Southpoint Blvd., Jacksonville, FL 32216, Reorder #137, 3 g/packet, Reorder #136, 4 oz.;
3. Novaplus, Manufactured for Novation, Inc., Irving, TX 75039, Manufactured by: Triad Group, Inc., 700 West North Shore Drive, Hartland, WI 53029, Cat. No. V10-8344, Net Wt. 3 grams, Cat. No. V10-8919, Net Wt. 4 oz., Cat. No. V10-8917, Net Wt. 2 oz.;
4. Triad Group, Inc., 700 West North Shore Drive, Hartland, WI 53029,
Cat. No. 10-8917, Net Wt. 2 oz,
Cat. No. 10-8946, Net Wt. 5 g,
Triad Plus Cat. No. 11-8344, 3 g.,
Cat. No. 11-8472, 5 grams,
Cat. No. 10-8919, Net Wt. 4 oz,
Cat. No. 10-8500, Net Wt. 4 oz;
5. IMCO, Manufactured for: Independent Medical Co-op, Inc., Daytona Beach, FL 32114. Reorder No. 8919-IMC Net Wt. 4 oz.;
6. McKesson Medi-Pak Performance, Marketed by McKesson Corporation, McKesson Surgical, Richmond, VA 23228. Reorder No. 66-8919, Net Wt. 4 oz.;
7. Henry Schein, Distributed by: Henry Schein Inc., Melville, NY 11747. 104-9637, Net Wt. 4 fl. oz.
||all Lot numbers beginning with the digits 7, 8, 9, or 0.
|H & P Industries, Inc. dba Triad Group
700 W North Shore Dr
Hartland, Wisconsin 53029-8358
|For Additional Information Contact
262-538-2900 Ext. 2761
|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.
||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.
|Quantity in Commerce
||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 countries including: Australia, Belgium, Canada, China, Lebanon, New Zealand, Philippines, Northern Marianna Islands, Saudi Arabia, Singapore, Taiwan, and United Arab Emirates.