FLEXOR TOUHY-BORST SIDE-ARM INTRODUCER (SHUTTLE SEECT) & FLEXOR CHECK-FLO INTRODUCER (2020-11-25)
- Starting date:
- November 25, 2020
- Posting date:
- December 24, 2020
- 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-74631
Last updated: 2020-12-24
Affected Products
- FLEXOR TOUHY-BORST SIDE-ARM INTRODUCER (SHUTTLE SELECT)
- FLEXOR CHECK-FLO INTRODUCER
Reason
For the impacted product lots, Cook Inc. has identified that there is an increased likelihood of the introducer sheath separating at the proximal bond site.
Affected products
A. FLEXOR TOUHY-BORST SIDE-ARM INTRODUCER (SHUTTLE SELECT)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- KSAW-5.0-38-90-RB-SHTL-FLEX-HC
- KSAW-6.0-38-90-RB-SHTL-FLEX-HC
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington, Indiana
47404
UNITED STATES
B. FLEXOR CHECK-FLO INTRODUCER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington, Indiana
47404
UNITED STATES