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U.S. Department of Health and Human Services

Class 2 Device Recall PHS (Professional Hospital Supply)

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  Class 2 Device Recall PHS (Professional Hospital Supply) see related information
Date Initiated by Firm June 11, 2003
Date Posted August 01, 2003
Recall Status1 Terminated 3 on December 16, 2003
Recall Number Z-1074-03
Recall Event ID 26526
510(K)Number K960803  
Product Classification unknown device name - Product Code : IPM
Product PHS, Tubular Stockinette Cotton, 6''x 48'' , 8''x 72'', 4''x 60'' and 4''x 48'' Double Ply, 6''x 72'', 4''x 48'' and 6''x 48''Single Ply and 4''x 4 YDS, 6''x 4 YDS and 3''x 4YDS, 1/pk 25 pk/cs, Manufactured for: Professional Hospital Supply, 41980 Winchester Rd, Temecula, CA 92590.
Code Information Lot #250512, Item #489150, 489230, 489267, 489305, 489310, 489347, 489433, 489374, 489412, 489427 and 499448. Lot #250514, Item #489150, 489230 and 489273.
Recalling Firm/
Manufacturer
Rx Textiles Inc
3107 Chamber Drive
Monroe NC 28110
For Additional Information Contact Walt Brittle
704-283-9787
Manufacturer Reason
for Recall
Product may not be sterile.
FDA Determined
Cause 2
Other
Action Distributor was notified via email on 6/11/2003 and advised to quarantine the product. A follow up letter was sent via certified mail to the distributor and to the contract packer on 6/18/2003 with a questionnaire and a self addressed stamped envelope to verify effectiveness.
Quantity in Commerce 141 cases 25pk/Cs
Distribution Product was shipped to one distribution center in CA who shipped product to consignees located in CA and NV.

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 = : IPM and Original Applicant = RX TEXTILES, INC.
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