| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00680-1 |
| Product Name/Description |
Various procedure packs containing BD Plastipak 50mL Syringe with Luer-Lok Tip
Multiple product names and pack codes
ARTG 136870
(Medline International Two Australia Pty Ltd - Surgical procedure kit, general-purpose, single-use, non-medicated)
ARTG 137395
(Medline International Two Australia Pty Ltd - Surgical procedure kit, general-purpose, single-use, non-medicated) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/05/2022 |
| Responsible Entity |
|
| Reason/Issue |
BD has received 2 complaints reporting an observation of air in damaged syringes for BD Plastipak 50mL Syringe with Luer-Lok Tip. When a damaged barrel syringe is used with a syringe pump, there is a possibility that ingress of air into the syringe could potentially inject air into the vascular system. Also, a flow rate fluctuation may occur altering the flow of medications within the syringe.
The affected component (manufactured by BD) is supplied by Medline within some procedure packs. The Medline procedure packs contain various components including drapes, gauze, gallipots, tubing, stopcock, needles and trays.
To date there have been no reports of adverse events received in Australia. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Medline are advising customers to:
1. Continue to follow the warnings on the Medline procedure pack labelling and good clinical practice regarding the inspection of medical devices for damage before, during and after use.
2. If a damaged syringe is identified:
· Please contact the Medline Account Manager so that a product complaint can be lodged.
· If necessary for the procedure, please utilise another unaffected sterile syringe and proceed.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 110 511 - Medline Customer Service |