Cooper Surgical

13 recalls •

• Categories: Surgical Instruments, Other Medical Devices

LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physician may choose from during the procedure.

Class I - Dangerous

LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) have Xylocaine (Lidocaine) HCL (2%) listed on the tray lid label but this is not included in the contents of the kit, which contained Polocaine (Mepivacaine) HCL (3%) instead (which was not listed on the tray label).

Feb 26, 2013 Surgical Instruments Nationwide View Details →

Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE3- A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Class I - Dangerous

Pessary mislabeled outer package may not reflect the size of the product contained in the package

Feb 26, 2013 Surgical Instruments Nationwide View Details →

Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Number: MXKPCONDS00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Class I - Dangerous

Pessary mislabeled outer package may not reflect the size of the product contained in the package

Feb 26, 2013 Surgical Instruments Nationwide View Details →

Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number: MXKPECH00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Class I - Dangerous

Pessary mislabeled outer package may not reflect the size of the product contained in the package

Feb 26, 2013 Surgical Instruments Nationwide View Details →

Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXKPCOND00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Class I - Dangerous

Pessary mislabeled outer package may not reflect the size of the product contained in the package

Feb 26, 2013 Surgical Instruments Nationwide View Details →

Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.

Class I - Dangerous

Incorrect size was printed on the outer product packaging.

Feb 26, 2013 Other Medical Devices View Details →

Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Class I - Dangerous

Pessary mislabeled outer package may not reflect the size of the product contained in the package

Feb 26, 2013 Surgical Instruments Nationwide View Details →

Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXPCOND00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Class I - Dangerous

Pessary mislabeled outer package may not reflect the size of the product contained in the package

Feb 26, 2013 Surgical Instruments Nationwide View Details →

Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex Part Number: MXPCON04 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Class I - Dangerous

Pessary mislabeled outer package may not reflect the size of the product contained in the package

Feb 26, 2013 Surgical Instruments Nationwide View Details →

Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: MXPGE2-3/4 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Class I - Dangerous

Pessary mislabeled outer package may not reflect the size of the product contained in the package

Feb 26, 2013 Surgical Instruments Nationwide View Details →

Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex :Part Number: MXPCONDS05 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Class I - Dangerous

Pessary mislabeled outer package may not reflect the size of the product contained in the package

Feb 26, 2013 Surgical Instruments Nationwide View Details →

Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy

Class I - Dangerous

Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle

Oct 31, 2012 Surgical Instruments Nationwide View Details →

Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy

Class I - Dangerous

Oct 31, 2012 Surgical Instruments Nationwide View Details →