Instrument Arm Drape, Disposable Accessory Kit, 3-Arm and 4-Arm (2018-08-31)
- Starting date:
- August 31, 2018
- Posting date:
- September 28, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67824
Affected products
- Instrument Arm Drape (Box of 20)
- Disposable Accessory Kit, 3-Arm (Box of 5)
- Disposable Accessory Kit, 4-Arm
Reason
The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product.
Affected products
A. Instrument Arm Drape (Box of 20)
Lot or serial number
D173337A
D173357
D180047A
D180057
D180127A
D180277
Model or catalog number
420015-03
Companies
- Manufacturer
-
Microtek Medical, Inc.
512 Lehmberg Road
Columbus
39702
Ohio
UNITED STATES
B. Disposable Accessory Kit, 3-Arm (Box of 5)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
420290-03
Companies
- Manufacturer
-
Microtek Medical, Inc.
512 Lehmberg Road
Columbus
39702
Ohio
UNITED STATES
C. Disposable Accessory Kit, 4-Arm
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
420291-03
Companies
- Manufacturer
-
Microtek Medical, Inc.
512 Lehmberg Road
Columbus
39702
Ohio
UNITED STATES