Health product recall

Various Medlines' Custom Procedure Packs (2018-04-06)

Starting date:
April 6, 2018
Posting date:
May 4, 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-66688

Affected products

A. Cesarienne-LF / C Section BJC-LF
B. Vaginal Delivery Pack
C. C-Section Pack-LF / C-Section-LF
D. New Tissue Retrieval MH
E. Ensemble A Cesarienne-LF
F. Vaginal Delivery Pack - LF

Reason

Medline Industries received a Medical Device Correction Notice from BD concerning their BD Vacutainer EDTA Lavender, Tan & Pink Top Tubes & BD Vacutainer Lithium Heparin Green Top Tubes. BD has recently determined that the curing agent thiuram, used in the processing of rubber stoppers since 1996, can lead to release of carbon disulfide (CS2) and carbonyl sulfide (COS) gases into the headspace of the tubes. These gases can dissolve into the blood sample to chelate lead, and therefore interfere with the accuracy of the Anodic Stripping Voltammetry (ASV) testing methodology.
The BD Vacutainer EDTA Lavender, Tan and Pink Top Tubes & BD Vacutainer Lithium Heparin Green Top Tubes are a component in several Medline Custom Procedure Packs.

Affected products

A. Cesarienne-LF / C Section BJC-LF

Lot or serial number

17WB9664
18MB3317
18NB1557

Model or catalog number

DYNJ41672X
DYNJ42677X

Companies
Manufacturer

Medline Industries Inc.

Three Lakes Drive

Northfield

60093

Illinois

UNITED STATES

B. Vaginal Delivery Pack

Lot or serial number

17KB1919
18CB1558

Model or catalog number

DYNJ47920X

Companies
Manufacturer

Medline Industries Inc.

Three Lakes Drive

Northfield

60093

Illinois

UNITED STATES

C. C-Section Pack-LF / C-Section-LF

Lot or serial number

18MB5551
18MB9683

Model or catalog number

DYNJ45915X
DYNJ47509X

Companies
Manufacturer

Medline Industries Inc.

Three Lakes Drive

Northfield

60093

Illinois

UNITED STATES

D. New Tissue Retrieval MH

Lot or serial number

17XB2402
18BB7218
18NB1353

Model or catalog number

DYNJ903849X

Companies
Manufacturer

Medline Industries Inc.

Three Lakes Drive

Northfield

60093

Illinois

UNITED STATES

E. Ensemble A Cesarienne-LF

Lot or serial number

18BB9026

Model or catalog number

DYNJ57105X

Companies
Manufacturer

Medline Industries Inc.

Three Lakes Drive

Northfield

60093

Illinois

UNITED STATES

F. Vaginal Delivery Pack - LF

Lot or serial number

17YB1732
181B4881
18OB3146

Model or catalog number

DYNJ45914X

Companies
Manufacturer

Medline Industries Inc.

Three Lakes Drive

Northfield

60093

Illinois

UNITED STATES