Z-0080-04

APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS, Stent Diameter: 7 FR., Length (Between Curl and...

Name: Z-0080-04 APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS, Stent Diameter: 7 FR., Length (Between Curl and...
Creator: Wilson-Cook Medical Inc
Published: 2003-07-25
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2003-07-25 / Terminated / root cause: labeling and UDI

FDA source

Wilson-Cook Medical Inc began a recall of APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS, Stent Diameter: 7 FR., Length (Between Curl and Flap): 4 CM, For Use With Wilson-Cook Stent... on 2003-07-25. The reason FDA records is "The label is missing the Rx Only symbol". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0080-04
Status: Terminated
Initiated: 2003-07-25
Posted: 2003-10-31
Terminated: 2003-12-04
Recalling firm: Wilson-Cook Medical Inc.
Product: APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS, Stent Diameter: 7 FR., Length (Between Curl and Flap): 4 CM, For Use With Wilson-Cook Stent Introduction System: 7 FR. Minimum Accessory Channel Size: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: The label is missing the Rx Only symbol.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The consignee was notified by the sales representative on/about July 29, 2003 via hand delivered letter. The consignee was informed of the recall and was advised to quarantine and return the affected product, via the Territory Manager. The consignee was urged to complete and return the response portion of the letter.
Quantity in commerce: 3 units
Distribution: Product was distributed to one account in IL.
Product codes and lots: Reorder #ZPSOF-7-4-RB, Lot #1615857, 1600284, 1600285.

Product code FGE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)