Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to r

FDA device recall Z-0488-2015 · posted 2014-12-01 · Terminated

Recall details

Recalling firm

CooperSurgical, Inc.

Reason for recall

The product has been identified to contain an incorrect curette type.

Action taken

CooperSurgical sent an Recall letter dated October 27, 2014, via UPS to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The subject device does not meet the required release specification as it contains an incorrect curette type. No adverse events or injuries have been reported to date in connection with the use of the CANNULA CURETTE. The event was discovered during internal investigation. Products that do not meet the above criteria are safe to use alongside the DFU guideline.The letter requests that customers return the recalled product for a full refund or exchange. If you have any further questions please feel free to call (203) 601.5200.

Root cause

Packaging process control

Status

Terminated

Product code

HHK

Quantity affected

30

Distribution

US Distribution including the states of NY, MO and NV.

Date initiated

2014-10-27

Date posted

2014-12-01

Date terminated

2015-05-28

Location

Trumbull, CT