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U.S. Department of Health and Human Services

Class 2 Device Recall Safety Introducer

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  Class 2 Device Recall Safety Introducer see related information
Date Initiated by Firm April 23, 2020
Date Posted May 14, 2020
Recall Status1 Terminated 3 on April 27, 2021
Recall Number Z-1982-2020
Recall Event ID 85586
Product Classification Syringe, piston - Product Code FMF
Product BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quick Kit. REF/UDI / 94115/10859821006251 - 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.
Code Information LOTS: 263650, 268325
Recalling Firm/
Manufacturer
Access Scientific LLC
3910 Sorrento Valley Blvd Ste 200
San Diego CA 92121-1419
For Additional Information Contact Martina Nguyen
585-259-8333
Manufacturer Reason
for Recall
Saline Flush Syringe compromised sterility due to holes in the packaging.
FDA Determined
Cause 2
Packaging
Action 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.
Quantity in Commerce 50 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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