Custom Procedure Packs with Non-X-Ray Detectable Cylindrical Sponges (2021-04-07)

Starting date:
April 7, 2021
Posting date:
April 22, 2021
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-75437

Last updated:

Affected Products

A. GEN TRACH,MED,THYROID SJHC-LF
B. ENT THYROID SJHC-LF
C. MINOR ABDOMINAL SJHC-LF
D. MAJOR UROLOGY SJHC-LF

Reason

Medline is recalling custom procedure packs containing non-x-ray detectable cylindrical sponges. The packs are supposed to contain x-ray detectable sponges. Beginning in May 2020, a substitution was approved to substitute Component 30082 (non-x-ray detectable cylindrical sponge) for Component 101097 (x-ray detectable cylindrical sponge) for 6 different CMP (Sterile Packs used in Complete Delivery Systems) work orders. These CMP's were then placed into 7 different Complete Delivery System (CDS) lots, see attached listing of affected products.

Affected products

A. GEN TRACH,MED,THYROID SJHC-LF

Lot or serial number

20GBE653
20KBH528
20KBJ006

Model or catalog number

DYNJ900780D

Companies
Manufacturer
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES

B. ENT THYROID SJHC-LF

Lot or serial number

20JBP200
20KBG180

Model or catalog number

DYNJ900778B

Companies
Manufacturer
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES

C. MINOR ABDOMINAL SJHC-LF

Lot or serial number

20KBF388

Model or catalog number

DYNJ900789B

Companies
Manufacturer
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES

D. MAJOR UROLOGY SJHC-LF

Lot or serial number

20FBL960

Model or catalog number

DYNJ900788F

Companies
Manufacturer
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES