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:
2021-04-22
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