Percutaneous Sheath Introducer Procedural Kits with Silk Sutures (2018-04-13)

Starting date:
April 13, 2018
Posting date:
May 11, 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-66728

Affected products

  1. PERCUTANEOUS SHEATH INTRODUCER PROCEDURAL KITS WITH SILK SUTURES
  2. INTRODUCER NEEDLES
  3. ARROWG+ARD CENTRAL VENOUS CATHETERIZATION KIT
  4. FLAT EPIDURAL FILTER
  5. SNAPLOCK CATHETER/SYRINGE ADAPTER
  6. SPRING WIRE GUIDE INTRODUCER CATHETER ASSEMBLY
  7. THERACATH SPRING WIRE EPIDURAL CATHETER
  8. CONTINUOUS EPIDURAL NEEDLE
  9. PERCUTANEOUS SHEATH INTRODUCER PROCEDURAL KITS
  10. ARROWG+ARD BLUE PLUS WITH BLUE FLEX TIP DOUBLE LUMEN CVC KIT
  11. ARROWG+ARD BLUE PLUS(R) W/BLUE FLEXTIP(R) TRIPLE LUMEN CVC KIT
  12. LOSS OF RESISTANCE SYRINGE
  13. CONTINUOUS NERVE BLOCK NEEDLES
  14. ARROWG+ARD BLUE PLUS ARROW-HOWES MULTI-LUMEN CENTRAL VENOUS CATH. SET
  15. CG+ ARROW PICC WITH CHLORAG+ARD TECHNOLOGY, NO PLACEMENT WIRE
  16. ARROW-JOHANS RIGHT ATRIAL ELECTROCARDIOGRAPHY (RAECG) ADAPTER
  17. VPS RHYTHM ECG ACCESSORY PACK
  18. VPS TIPTRACKER STYLET ACCESSORY
  19. MAXIMAL BARRIER DRAPE
  20. CATHETER CLAMP WITH FASTENER
  21. ACCESSORY KIT, SHEATH ADAPTER WIT CATH-GARD CONTAMINATION SHIELD
  22. EXTERNAL LINE SLIDE CLAMP COMPONENT

Reason

Arrow International is recalling the product because the packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed. If a non-sterile product is used, there is potential for infection to occur. No patient injuries have been reported related to this issue.

Affected products

A. PERCUTANEOUS SHEATH INTRODUCER PROCEDURAL KITS WITH SILK SUTURES

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

ASK-09907-SB

Companies
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

B. INTRODUCER NEEDLES

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • AN-04318
  • AN-04320
Companies
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

C. ARROWG+ARD CENTRAL VENOUS CATHETERIZATION KIT

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

ASK-24306-VC

Companies
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

D. FLAT EPIDURAL FILTER

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

EF-05500

Companies
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

E. SNAPLOCK CATHETER/SYRINGE ADAPTER

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

AS-05500

Companies
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

F. SPRING WIRE GUIDE INTRODUCER CATHETER ASSEMBLY

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

CN-04018

Companies
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

G. THERACATH SPRING WIRE EPIDURAL CATHETER

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

EC-05000

Companies
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

H. CONTINUOUS EPIDURAL NEEDLE

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • AN-05501
  • AN-05505
Companies
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

I. PERCUTANEOUS SHEATH INTRODUCER PROCEDURAL KITS

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

ASK-09803-SRH

Companies
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

J. ARROWG+ARD BLUE PLUS WITH BLUE FLEX TIP DOUBLE LUMEN CVC KIT

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • ASK-42802-VC
  • ASK-47702-VC
Companies
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

K. ARROWG+ARD BLUE PLUS(R) W/BLUE FLEXTIP(R) TRIPLE LUMEN CVC KIT

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • ASK-42703-RV1
  • ASK-45703-VC
Companies
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

L. LOSS OF RESISTANCE SYRINGE

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

LR-05501

Companies
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

M. CONTINUOUS NERVE BLOCK NEEDLES

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • AB-17080-N
  • AB-17140-N
Companies
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

N. ARROWG+ARD BLUE PLUS ARROW-HOWES MULTI-LUMEN CENTRAL VENOUS CATH. SET

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

ASK-42703-VC

Companies
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

O. CG+ ARROW PICC WITH CHLORAG+ARD TECHNOLOGY, NO PLACEMENT WIRE

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • PR-45541-HPHNL
  • PR-45541-HPHNM
  • PR-45552-HPHNL
  • PR-45552-HPHNM
Companies
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

P. ARROW-JOHANS RIGHT ATRIAL ELECTROCARDIOGRAPHY (RAECG) ADAPTER

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

EG-04900

Companies
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

Q. VPS RHYTHM ECG ACCESSORY PACK

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

RHY-100-ECGJ

Companies
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

R. VPS TIPTRACKER STYLET ACCESSORY

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

RHY-177-TTSAP

Companies
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

S. MAXIMAL BARRIER DRAPE

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

ASK-00002-1A

Companies
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

T. CATHETER CLAMP WITH FASTENER

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • CC-00004
  • CC-00005
  • CC-00007
  • CC-00008
Companies
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

U. ACCESSORY KIT, SHEATH ADAPTER WIT CATH-GARD CONTAMINATION SHIELD

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

SA-09847

Companies
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

V. EXTERNAL LINE SLIDE CLAMP COMPONENT

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number

SC-14703

Companies
Manufacturer
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES