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.
FDA Recall Z-1074-03 · Posted 2003-08-01
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Recalling FirmRx Textiles Inc
Recall StatusTerminated
Product Code:
Date Initiated2003-06-11
Date Terminated2003-12-16
Product Quantity141 cases 25pk/Cs
Reason for Recall
Product may not be sterile.
Firm 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.
Root Cause
Other
Distribution Pattern
Product was shipped to one distribution center in CA who shipped product to consignees located in CA and NV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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