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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
March 24, 1999

PRODUCT
Leep Redikit for Gynecological Loop Electrosurgical Excision Procedure, Part #6060. Recall #D-143-9.

CODE
Lot Numbers:  711054L   711144L   711184L   711194L    712124L
712164L   712174L   712184L   712314L   801224L    801234L
802184L   802254L   803054L   803124L   803234L    804014L
804024E   804204E   804294E   80810E     81008E    81024E
81027E    81110E    81122E    81125E     90120E    90129E
90201E.

MANUFACTURER
Cooper Surgical, Inc., Shelton, Connecticut.

RECALLED BY
Manufacturer, by letter on March 1, 1999. Firm-initiated recallongoing.

DISTRIBUTION
Nationwide.

QUANTITY
27,622 kits were distributed.

REASON
Lack of assurance of sterility for Novocol brand/manufacturedOctocaine 100 (Lidocaine HCL 2% and Epinephrine 1:100,000) 1.8Ml Cartridges packaged in each kit.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.