Z-0593-2007

POOLE Suction Instrument, REF 0035040. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY...

Name: Z-0593-2007 POOLE Suction Instrument, REF 0035040. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY...
Creator: Conmed Corporation
Published: 2006-11-10
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2006-11-10 / Terminated / root cause: packaging

FDA source

Conmed Corporation began a recall of POOLE Suction Instrument, REF 0035040. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 13501. ASSEMBLED IN MEXICO on 2006-11-10. The reason FDA records is "Firm was made aware of instances where the sterile barrier of the instruments had been compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0593-2007
Status: Terminated
Initiated: 2006-11-10
Posted: 2007-03-13
Terminated: 2012-07-31
Recalling firm: ConMed Corporation
Product: POOLE Suction Instrument, REF 0035040. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 13501. ASSEMBLED IN MEXICO.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Firm was made aware of instances where the sterile barrier of the instruments had been compromised.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On 11/10/06, ConMed Corp. sent "URGENT: DEVICE RECALL" letters (dated 11/10/06) to the US and foreign consignees by UPS overnight. The letters instructed the consignees to inspect their stocks of the instruments and that they return all devices. The letters also instructed the distributors to contact their customers that received the instruments and conduct sub-recalls. Additionally, when requested, ConMed notified the distributor's customers (conducted sub-recalls) by UPS overnight mail. This recall action is to the end user level. Accompanying each letter was an effectiveness check form to be completed by the consignee, and faxed back to ConMed Corp. The instruments are to be returned to ConMed Corp. in Utica, NY. For questions, the consignee can contact Ms. Nancy Crisino by phone at (315) 624-3078 or by fax at (315) 624-3089.
Quantity in commerce: 2,232,896 units
Distribution: Worldwide
Product codes and lots: REF 0035040; All lots manufactured between 10/04/2001 and 10/04/2006. Lot codes on boxes and packaging contain a 7 digit lot code: For example, lot 0409271: the first 2 digits represent the year manufactured (04 represents 2004), next 2 digits represent the month (09 represents September), the next 2 digits represent the day of the month (27), and the last digit represents the manufacturing shift code (1).

Product code GCJ

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)