STAT 2 Pumpette I.V. Compensating Controller, Catalog/REF No. PS2, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH R

FDA device recall Z-0682-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

ConMed Corporation

Reason for recall

ConMed received 16 complaints for STAT 2 Pumpette devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investigation of the complaints determined that the STAT 2 Pumpette Compensating Controller on several complaint samples had been assembled incorrectly.

Action taken

ConMed sent an "Urgent Medical Device Recall" letters and Reply Forms dated April 15, 2011 to the domestic consignees via UPS Priority Mail pouches and to the foreign consignees via FedEx International Priority. The letter identified the product, description of problem, and actions to be taken. Consignees were instructed to review their inventory and immediately stop use of the affected devices and return them to ConMed Corporation. Consignees who had distributed the affected products outside of their facility were instructed to immediately notify their customers of the recall and provide them with a copy of this notice. Consignees were asked to complete and return the enclosed Reply Form. For questions call 315-624-3237 or email ivcontroller@conmed.com

Root cause

Device Design

Status

Terminated

Product code

LDR

Quantity affected

1,146,741 sets in total

Distribution

Worldwide Distribution - USA (nationwide) - including the countries of: Australia, Barbados, Belgium, Bermuda, Canada, Egypt, Israel, India, Italy, Korea, New Zealand, Philippines and Saudi Arabia.

Date initiated

2011-04-15

Date posted

2012-01-11

Date terminated

2012-11-20

Location

Utica, NY

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