| Class 2 Device Recall PHS (Professional Hospital Supply) | |
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
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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
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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. |
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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.
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510(K) Database | 510(K)s with Product Code = : IPM
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