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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile Lubricating Jelly

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 Class 2 Recall
Sterile Lubricating Jelly
see related information
Date Posted January 21, 2011
Recall Status1 Terminated on June 11, 2012
Recall Number Z-0934-2011
Recall Event ID 57612
Premarket Notification
510(K) Number
K871169 
Product Classification Lubricant, Patient - Product Code KMJ
Product 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. Brand names: 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.
Code Information all Lot numbers beginning with the digits 7, 8, 9, or 0.
Recalling Firm/
Manufacturer
H & P Industries, Inc. dba Triad Group
700 W North Shore Dr
Hartland, Wisconsin 53029-8358
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Customer Service
262-538-2900 Ext. 2761
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action 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 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 countries including: Australia, Belgium, Canada, China, Lebanon, New Zealand, Philippines, Northern Marianna Islands, Saudi Arabia, Singapore, Taiwan, and United Arab Emirates.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KMJ and Original Applicant = H & P INDUSTRIES, INC.
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