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Terminated

Medtronic Zinetics Manometric Catheter, Model 9012P2271. Water perfused, motility catheter. Distributed by Medtronic, Inc. 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604 USA.

FDA Recall Z-1159-06 · Posted 2006-06-22

Recalling FirmMedtronic Gastroenterology / Urology
Recall StatusTerminated
Product CodeKLA
Date Initiated2006-04-06
Date Terminated2007-01-16
Product Quantity94 catheters (US - 4; OUS - 90)

Reason for Recall

Mislabeling- The 8 ports of the manometric catheter were incorrectly labeled 1,3,5,7,8,2,4,6 from the distal to the proximal end of the catheter. The correct port configuration is sequentially 1 through 8, from the distal to the proximal end of the catheter.

Firm Action

Recall initiated to International accounts on 04/05/06 and within US on 04/06/06 via an Urgent Recall Notification. The letter informs them of the manufacturing defect, requests return for credit of any unused inventory and requests accounting of all previously used catheters. Distributors are instructed to sent a letter to their customers to request product return.

Root Cause

Other

Distribution Pattern

Worldwide Distribution-including states of IL, NC, NY. and countries of Austria, Chile, Finland, Germany, Greece, Hong Kong, Italy, Japan, Lebanon, Norway, Peru, Portugal, Saudi Arabi, Spain

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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