BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quick Kit. REF/UDI / 94105/10859821006190 - Pro
FDA device recall Z-1975-2020 · 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
- 6.066 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
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.