Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
Labeling: Incorrect or Missing Lot and/or Exp Date
The fastening post hardware could loosen allowing the fastening post to detach from the cot
The fastening post hardware could loosen allowing the fastening post to detach from the cot
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Ferno-Washington Inc or your healthcare provider for instructions. Notification method: Letter
FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES.. Reason: The fastening post hardware could loosen allowing the fastening post to detach from the cot. Classification: Class II. Quantity: 138 units. Distribution: US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, IS, IL, KY, LA, MN, MO, NC, ND, NE, NM, NY, OH, OK, PA, TN, TX, UT, VA, WI, WV.
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Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Labeling: Incorrect or Missing Lot and/or Exp Date