Health product recall

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 

  1. FLEXOR TOUHY-BORST SIDE-ARM INTRODUCER (SHUTTLE SELECT)
  2. 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