PDS Plus Antibacterial Suture CL, Vl and Vl (Loop) (2019-12-23)
- Starting date:
- December 23, 2019
- Posting date:
- January 10, 2020
- 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-72089
Last updated: 2020-01-10
Affected Products
- PDS Plus Antibacterial Suture CL
- PDS Plus Antibacterial Suture VL
- PDS Plus Antibacterial Suture VL (Loop)
Reason
Certain product codes and lot numbers were distributed with instructions for use that are not approved by Health Canada. The instructiosn for use includes an indication for the use in pediatric tissue. In Canada, PDS* Plus Antibacterial Suture are not indicated for use in pediatric tissue.
Affected products
-
PDS Plus Antibacterial Suture CL
Lot or serial number
- PB5163
- PBU274
Model or catalog number
PDP443H
Companies
- Manufacturer
-
Ethicon LLC
475C Street, Los Frailes Industrial Park, Suite 401
Guaynabo
00969
PUERTO RICO
B. PDS Plus Antibacterial Suture VL
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
PDP304H
PDP315H
PDP317H
PDP332H
PDP333H
PDP334H
PDP338H
PDP346H
PDP347H
PDP352H
PDP371T
PDP463G
Companies
- Manufacturer
-
Ethicon LLC
475C Street, Los Frailes Industrial Park, Suite 401
Guaynabo
00969
PUERTO RICO
C. PDS Plus Antibacterial Suture VL (Loop)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
PDP990G
PDP991G
Companies
- Manufacturer
-
Ethicon LLC
475C Street, Los Frailes Industrial Park, Suite 401
Guaynabo
00969
PUERTO RICO