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U.S. Department of Health and Human Services

Class 2 Device Recall Biogel Skinsense N Surgical Gloves

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  Class 2 Device Recall Biogel Skinsense N Surgical Gloves see related information
Date Initiated by Firm November 25, 2002
Date Posted December 18, 2002
Recall Status1 Terminated 3 on July 21, 2003
Recall Number Z-0346-03
Recall Event ID 25119
510(K)Number K000421  
Product Classification Surgeon'S Gloves - Product Code KGO
Product Biogel Skinsense N, Non-Latex, Powder-free Surgical Gloves with Biogel coating, Neoprene, Made from a synthetic Elastomer, Sterile/R, REGENT, Made in Malaysia, Regent Medical, Norcross, GA USA 30092, 1-800-843-8497, Toft Hall, Knotsford, Cheshire WA16 9PD, TEL: +44 (0) 1565 624000, Regent Medical is a Member of SSL International plc.

Lot Number 01H0161 through 01H2668, sizes: 7-7 ¿ , One Pair sterile gloves packaged 50 pair per box/ 4 boxes per case/ total 200 pair per case.
Code Information Lot numbers 01H0161 through 01H2668
Recalling Firm/
Manufacturer		 SSL Americas Inc.
3585 Engineering Dr.
Norcross GA 30092
For Additional Information Contact Mr. Milt Hinsch
770-582-2111
Manufacturer Reason
for Recall		 Sulfur particles on the surface of gloves.
FDA Determined
Cause 2		 Other
Action On 11/25/2002 the Company representatives contacted the headquarter offices of the firm's in the U.S. by telephone and in writing by UPS delivery. On 11/26/2002 the Company sent the distributors' branches letters via UPS delivery. Approximately 1500 hospitals (customers of the Company's distributors) were notified by letter via UPS delivery. Customers were instructed to cease distribution of the suspected lot number gloves, contact their customers, and return any remaining gloves via UPS to the recalling firm. A response letter is attached to the recall letter. The Company intends to contact by telephone all of its direct accounts who do not respond to the Recall Letter.
Quantity in Commerce 173,310 pairs
Distribution Various Hospitals, Direct accounts,and Company sales representatives in: AL, AZ,, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, MN, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SD, TN, TX, VA, VT, WA, WI. Foreign Accounts in: Canada, Venezuela and British Colombia. SSL Canada, Concord, Canada; Corporacion Alivari, Caracas, Venezuela; and Wilhelmina Martin, Port Moody, British Colombia. No government accounts involved.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KGO and Original Applicant = SSL AMERICAS, INC. (REGENT MEDICAL)
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