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Z-2254-2013 Class II Terminated

Recalled by Access Scientific Inc — San Diego, CA

FDA device recall Z-2254-2013 was initiated by Access Scientific Inc on August 16, 2013 and is designated Class II. Reason for recall: Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled. The recall status is terminated (terminated September 24, 2013). Affected quantity: 160 units.

Recall Details

Product Type
Devices
Report Date
September 25, 2013
Initiation Date
August 16, 2013
Termination Date
September 24, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
160 units

Product Description

POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system to sample blood and administer fluids intravenously.

Reason for Recall

Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled.

Distribution Pattern

Distributed in MI and TX.

Code Information

Lot no. I666473

Other recalls by Access Scientific Inc

  • Z-2550-2020 Class III — POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Cath (June 15, 2020)
  • Z-1975-2020 Class II — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quick K (April 23, 2020)
  • Z-1976-2020 Class II — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barr (April 23, 2020)
  • Z-1972-2020 Class II — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6 (April 23, 2020)
  • Z-1983-2020 Class II — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barr (April 23, 2020)
  • Z-1979-2020 Class II — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extende (April 23, 2020)
  • Z-1977-2020 Class II — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max Bar (April 23, 2020)
  • Z-1981-2020 Class II — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatri (April 23, 2020)
  • Z-1973-2020 Class II — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site K (April 23, 2020)
  • Z-1982-2020 Class II — BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quick K (April 23, 2020)

FDA data resources