Laparoscopic cholecystectomy pack TBRHSC-LF, General laparoscopy CDS, Major GYN laparoscopy CDS, GYNE major laparoscopy GRH-LF, Hepatobiliaire laparoscopie-LF, Major laparoscopic SJHC-LF, Ensemble thoraco-LF, Laparoscopy RVHS-LF, and Laparoscopie chi...
- Starting date:
- May 29, 2019
- Posting date:
- June 14, 2019
- 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-70209
Last updated: 2019-06-14
Affected Products
A. Laparoscopic cholecystectomy pack TBRHSC-LF
B. General laparoscopy CDS
C. Major GYN laparoscopy CDS
D. GYNE major laparoscopy GRH-LF
E. Hepatobiliaire laparoscopie-LF
F. Major laparoscopic SJHC-LF
G. Ensemble thoraco-LF
H. Laparoscopy RVHS-LF
I. Laparoscopie chirurgicale-LF
Reason
Medline is recalling custom procedure packs containing Medline anti-fog solution. Medline has issued this recall because the anti-fog solution may not defog properly due to degradation in the chemical properties. Although the device failure is visually apparent and easily recognizable to the user as fog will be present in the endoscopic/laparoscopic instrument, the visual field may not be clear and there is a potential for a delay in the procedure.
Affected products
A. Laparoscopic cholecystectomy pack TBRHSC-LF
Lot or serial number
19BBG785
Model or catalog number
DYNJ41939A
Companies
- Manufacturer
-
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES
B. General laparoscopy CDS
Lot or serial number
19BBM834
Model or catalog number
CDS983989C
Companies
- Manufacturer
-
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES
C. Major GYN laparoscopy CDS
Lot or serial number
19BBR816
Model or catalog number
CDS984007B
Companies
- Manufacturer
-
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES
D. GYNE major laparoscopy GRH-LF
Lot or serial number
19ABN541
Model or catalog number
DYNJ41789C
Companies
- Manufacturer
-
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES
E. Hepatobiliaire laparoscopie-LF
Lot or serial number
19ABN648
Model or catalog number
DYNJ47554B
Companies
- Manufacturer
-
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES
F. Major laparoscopic SJHC-LF
Lot or serial number
19BBF368
19CBS603
Model or catalog number
DYNJ900787C
Companies
- Manufacturer
-
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES
G. Ensemble thoraco-LF
Lot or serial number
19BBQ917
Model or catalog number
DYNJ48752A
Companies
- Manufacturer
-
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES
H. Laparoscopy RVHS-LF
Lot or serial number
19BBU487
Model or catalog number
DYNJ46864
Companies
- Manufacturer
-
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES
I. Laparoscopie chirurgicale-LF
Lot or serial number
19BBT963
Model or catalog number
DYNJ58542A
Companies
- Manufacturer
-
Medline Industries Inc.
Three Lakes Drive
Northfield
60093
Illinois
UNITED STATES