Device product
Portex¿ Saddleblock Tray with Drugs 25g Quincke; 4795-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure.
Z-0164-2014
Product summary
- Event
- Event 66351
- Status
- Terminated
- Classification
- Class II
- Quantity
- 222
- Official record key
device-enforcement:Z-0164-2014
Official wording
Reason: Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays.
Code information: Lot: 2455104
Distribution pattern: Nationwide Distribution including AK, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, VT, WA, WI, WY.
Derived failure modes
-
Foreign material or chemical contamination
particulate