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Health product recall

Pinnacle Introducers and Precision Access System (2016-03-11)

Starting date:
March 11, 2016
Posting date:
March 29, 2016
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-57676

Affected products 

  1. Pinnacle R/O II Introducer Sheath
  2. Pinnacle Introducer Sheath
  3. Pinnacle TIF Introducer Sheath
  4. Pinnacle Precision Access System

Reason

Terumo Medical Corporation is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue. If affected introducer sheaths are used, there is possible risk of incremental blood loss through the valve.

Affected products

A. Pinnacle R/O II Introducer Sheath  

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • RSB402
  • RSB403
  • RSB412
  • RSB502
  • RSB503
  • RSB601
  • RSB602
  • RSB603
  • RSB701
  • RSB702
  • RSB703
  • RSB802
  • RSB902
Companies
Manufacturer
Terumo Medical Corporation
950 Elkton Blvd
Elkton
21921
Maryland
UNITED STATES

B. Pinnacle Introducer Sheath  

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • RSS402
  • RSS404
  • RSS502
  • RSS504
  • RSS506
  • RSS602
  • RSS604
  • RSS606
  • RSS702
  • RSS704
  • RSS802
  • RSS804
  • RSS806
Companies
Manufacturer
Terumo Medical Corporation
950 Elkton Blvd
Elkton
21921
Maryland
UNITED STATES

C. Pinnacle TIF Introducer Sheath  

Lot or serial number
  • TG24
  • TH29
  • TK19
  • TK26
  • TL23
  • TM21
Model or catalog number
  • 10-2531
  • 10-2532
  • 10-2533
  • 10-2534
Companies
Manufacturer
Terumo Medical Corporation
950 Elkton Blvd
Elkton
21921
Maryland
UNITED STATES

D. Pinnacle Precision Access System

Lot or serial number
  • TK05
  • TL02
Model or catalog number
  • 70-5130
  • 70-5160
  • 70-6130
Companies
Manufacturer
Terumo Medical Corporation
950 Elkton Blvd
Elkton
21921
Maryland
UNITED STATES

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