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U.S. Department of Health and Human Services

Class 2 Device Recall Atrapro Antipruritic Hydrogel, 1.5 oz gel tube

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 Class 2 Recall
Atrapro Antipruritic Hydrogel, 1.5 oz gel tube
see related information
Date Posted February 26, 2013
Recall Status1 Terminated on November 25, 2013
Recall Number Z-0890-2013
Recall Event ID 64316
Premarket Notification
510(K) Number
K012945 
Product Classification Dressing, Wound, Drug - Product Code FRO
Product Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional Sample, Not for Sale. Pre-printed tube: MS31071, Shelf carton: PL51091-08 Atrapro Antipruritic HydroGel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis.
Code Information Lot 12A0012, Exp 2/2013; Lot 12A0013, Exp 2/2013: Lot 12A1116, Exp 2.2013; Lot 12A1119, Exp 2/2013; Lot 12B1144, Exp 3/2013; Lot 12B1148, Exp 3/2013; Lot 12C1157, Exp 4/2013; Lot 12E190. Exp 6/2013; Lot 12E194, Exp 6/2013; Lot 12E198, Exp 6/2013; Lot 12E202. Exp 6/2013; Lot 12E208, Exp 6/2013; Lot 12E211, Exp 6/2013.
Recalling Firm/
Manufacturer
Oculus Innovative Sciences Inc
1129 N Mcdowell Blvd
Petaluma, California 94954-1110
For Additional Information Contact Robert Miller
707-559-7191 Ext. 14
Manufacturer Reason
for Recall
Out of specification result - stability test failure of free available chlorine (FAC) which functions as a preservative for the hydrogel. The 13 month test result obtained was 4 ppm FAC and the stability specification is >10 ppm FAC.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Oculus sent an Urgent Medical Device Recall letter dated February 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue distribution and segregate the affected product. Immediately remove the affected lots of Recall product from the inventory of sales representative, sub contracted distribution and or fulfillment centers. Segregate the affected product in a secure location for return or destruction. If the product was further distributed customers were instructed to notify healthcare professionals of this recall. Customers were also instructed to completed and return the Business Reply Card and fax to 1-415-462-5163. Once the firm receives the affected product the customer would be contacted by an Oculus Representative and provided a Returns Goods Authorization (RGA) number. For questions customers were instructed to call 1-707-559-2445. For questions regarding this recall 707-559-7191, ext 14.
Quantity in Commerce 56,566 1.5 oz tubes
Distribution Nationwide Distribution - One distributor in PA
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 = FRO and Original Applicant = SYNTHES (USA)
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