Recall Z-0591-2007
Conmed Corporation · initiated November 10, 2006
Product
FRAZIER Surgical Suction Instrument, 18 Fr. with Obturator, REF 0033180. MANUFACTURED FOR CONMED CORPORATION 310 Broad Street, Utica, NY 13501. ASSEMBLED IN MEXICO.
Codes / lots: REF 0033180; 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).
Reason for recall
Firm was made aware of instances where the sterile barrier of the instruments had been compromised.
FDA-determined cause: Packaging process control
Action taken
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.
Details
- Recall number
- Z-0591-2007
- Initiated
- November 10, 2006
- Posted by FDA
- March 13, 2007
- Terminated
- July 31, 2012
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Quantity
- 357,017 units
- Distribution
- Worldwide
- Recalling firm
- Conmed Corporation, Utica, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0584-2007 | FRAZIER Surgical Suction Instrument, 3 Fr. with Control Vent and Obturator, REF 0031030.…Firm was made aware of instances where the sterile barrier of the instruments had been compromised. | 11/10/2006Terminated |
| Z-0585-2007 | FRAZIER Surgical Suction Instrument, 5 Fr. with Control Vent and Obturator, REF 0031050.…Firm was made aware of instances where the sterile barrier of the instruments had been compromised. | 11/10/2006Terminated |
| Z-0586-2007 | FRAZIER Surgical Suction Instrument, 7 Fr. with Control Vent and Obturator, REF 0031070.…Firm was made aware of instances where the sterile barrier of the instruments had been compromised. | 11/10/2006Terminated |
| Z-0587-2007 | FRAZIER Atraumatic Soft Tip Surgical Suction Instrument with Control Vent and Obturator…Firm was made aware of instances where the sterile barrier of the instruments had been compromised. | 11/10/2006Terminated |
| Z-0588-2007 | FRAZIER Surgical Suction Instrument, 8 Fr. with Control Vent and Obturator, REF 0033080.…Firm was made aware of instances where the sterile barrier of the instruments had been compromised. | 11/10/2006Terminated |
| Z-0589-2007 | FRAZIER Surgical Suction Instrument, 10 Fr. with Control Vent and Obturator, REF…Firm was made aware of instances where the sterile barrier of the instruments had been compromised. | 11/10/2006Terminated |
| Z-0590-2007 | FRAZIER Surgical Suction Instrument, 12 Fr. with Control Vent and Obturator, REF…Firm was made aware of instances where the sterile barrier of the instruments had been compromised. | 11/10/2006Terminated |
| Z-0592-2007 | FRAZIER Olive Tip Suction Instrument, 10 Fr. with Control Vent and Obturator (Bend with…Firm was made aware of instances where the sterile barrier of the instruments had been compromised. | 11/10/2006Terminated |
| Z-0593-2007 | POOLE Suction Instrument, REF 0035040. MANUFACTURED FOR CONMED CORPORATION, 310 Broad…Firm was made aware of instances where the sterile barrier of the instruments had been compromised. | 11/10/2006Terminated |