Z-0158-2014Class II
Portex Spinal Tray with Drugs 25g Whitacre; 15545C-21 The Regional Anesthesia family of products is comprised...
Abbott Medical / initiated 2013-09-23 / Terminated / root cause: manufacturing process
Smiths Medical ASD, Inc. began a recall of Portex Spinal Tray with Drugs 25g Whitacre; 15545C-21 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0158-2014
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Abbott Medical
- Product
- Portex Spinal Tray with Drugs 25g Whitacre; 15545C-21 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.
- Product code
- CAZ Anesthesia Conduction Kit
- Reason for recall
- 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.
- Root cause tag
- manufacturing process
- FDA root cause
- Material/Component Contamination
- Action
- Smiths Medical sent an Urgent Recall Notice dated September 23, 2013, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory for the affected product and remove from use. Complete the Confirmation Form and return by fax to 603-358-1017 or by email to [email protected]. Upon receipt of the completed form, a customer service representative would contact them to arrange for exchange of their unused affected devices for credit or replacement. Customers were also instructed to forward the notice to all personnel who need to be aware within their organization. Customers with questions were instructed to contact Smiths Medical's Customer Service Department at 800-258-5361. For questions regarding this recall call 800-258-5361.
- Quantity in commerce
- 830
- Distribution
- 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.
- Product codes and lots
- Lot Number: 2440517
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0156-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0157-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0158-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0159-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0160-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0161-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0162-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0163-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0164-2014 | Class II | Terminated | Voluntary: Firm initiated |
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