Z-1074-03

PHS, Tubular Stockinette Cotton, 6''x 48'' , 8''x 72'', 4''x 60'' and 4''x 48'' Double Ply, 6''x 72'', 4''x...

Name: Z-1074-03 PHS, Tubular Stockinette Cotton, 6''x 48'' , 8''x 72'', 4''x 60'' and 4''x 48'' Double Ply, 6''x 72'', 4''x...
Creator: Rx Textiles Inc
Published: 2003-06-11
License: https://open.fda.gov/license/

Paceline, Inc. / initiated 2003-06-11 / Terminated / root cause: sterility

FDA source

Rx Textiles Inc began a recall of 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... on 2003-06-11. The reason FDA records is "Product may not be sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1074-03
Status: Terminated
Initiated: 2003-06-11
Posted: 2003-08-01
Terminated: 2003-12-16
Recalling firm: Paceline, Inc.
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.
Product code: :
Reason for recall: Product may not be sterile.
Root cause tag: sterility
FDA root cause: 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.
Product codes and lots: Lot #250512, Item #489150, 489230, 489267, 489305, 489310, 489347, 489433, 489374, 489412, 489427 and 499448. Lot #250514, Item #489150, 489230 and 489273.

Product code :

K960803Class IIRx Textiles Sterile StockinetteRx Textiles, Inc. / cleared 1996-07-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)