Recall Z-1983-2020
Access Scientific LLC · initiated April 23, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 94116/10859821006237 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.
Codes / lots: LOTS: 267011
Reason for recall
Saline Flush Syringe compromised sterility due to holes in the packaging.
FDA-determined cause: Packaging
Action taken
Customer Service Department will send the Advisory Notice and Recall Response Form to all affected levels of the distribution chain. On 04/23/2020, the firm sent an Urgent: Medical Device Recall letter to heir distributors and hospitals requesting them to discard all BD PosiFlush" SF Saline Flush Syringe 10 ml (part number 306553) from the convenience kits.
Details
- Recall number
- Z-1983-2020
- Initiated
- April 23, 2020
- Posted by FDA
- May 14, 2020
- Terminated
- April 27, 2021
- Product code
- FMF – Syringe, Piston
- Quantity
- 110 units
- Distribution
- US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA.
- Recalling firm
- Access Scientific LLC, San Diego, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1972-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm.…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |
| Z-1973-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site Kit, 4Fr…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |
| Z-1974-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit.…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |
| Z-1975-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quick Kit.…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |
| Z-1976-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barrier Kit.…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |
| Z-1977-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max Barrier…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |
| Z-1978-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick Kit.…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |
| Z-1979-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |
| Z-1980-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick Kit.…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |
| Z-1981-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatric Kit.…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |
| Z-1982-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quick Kit.…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |