BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barrier Kit. REF/UDI / 94106/10859821006176
FDA device recall Z-1976-2020 · posted 2020-05-14 · Terminated
Recall details
- Recalling firm
- Access Scientific LLC
- Reason for recall
- Saline Flush Syringe compromised sterility due to holes in the 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.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 1,864 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.
- Date initiated
- 2020-04-23
- Date posted
- 2020-05-14
- Date terminated
- 2021-04-27
- Location
- San Diego, CA
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