Health product recall

VPS Rhythm ECG Accessory Pack with Johans Adapter and VPS TipTracker Stylet Accessory (2018-05-17)

Starting date:
May 17, 2018
Posting date:
June 1, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66956

Affected products

A. VPS Rhythm ECG Accessory Pack with Johans Adapter
B. VPS TipTracker Stylet Accessory

Reason

Arrow International is issuing this notice for the product referenced above because the products pouch label may not contain the human-readable lot number, expiration date and associated symbols. The data is present and visible in the UDI section of the label.

Affected products

A. VPS Rhythm ECG Accessory Pack with Johans Adapter

Lot or serial number

13F17A0287

Model or catalog number

RHY-100-ECGJ

Companies
Manufacturer

Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)

2400 Bernville Road

Reading

19605

Pennsylvania

UNITED STATES

B. VPS TipTracker Stylet Accessory

Lot or serial number

13F17G0074

Model or catalog number

RHY-177-TTSAP

Companies
Manufacturer

Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)

2400 Bernville Road

Reading

19605

Pennsylvania

UNITED STATES