Recall Z-1140-2010 ยท FMI Needle, Hypodermic, Single Lumen
Centurion Medical Products
Centurion Healthcare Products Pump Fill Kit DT10175. CONTENTS: 1 CSR WRAP, 2 GLOVES, 1 FENESTRATED DRAPE, 1 EXTENSION LINE Approx. Priming Vol.: 0.3mL, 1 SYRINGE, 1 Exel Huber NEEDLE, 1 ChloraPrep(R), 1 TRAY The recalled Exel Huber Needles are used to access subcutaneously implanted ports used for the withdrawal of blood samples and infusion of medication. The firm places the recalled needles in
| Date | Mar 15, 2010 (initiated Feb 1, 2010) |
| Status | Terminated |
| Reason | A supplier notified this firm of a recall of their Huber needles because the needles that are labeled as non-coring could core 60-72% of the time. Centurion is doing a sub recall of their kits that contain the referenced needles. |
| Root cause | Other |
| Action | An "URGENT MEDICAL DEVICE WITHDRAWAL" notice dated January 26, 2010, was sent to customers via certified mail. The notice described the product, problem and action to be taken by the customers. The customers were instructed: DO NOT USE THESE AFFECTED PRODUCTS. PLEASE RETURN ALL AFFECTED PRODUCTS IN ACCORDANCE WITH THE INSTRUCTIONS PROVIDED. The customers were also instructed to report any adverse reactions experienced with the use of the product and/or quality problems to MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-1078 by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, R |
| Quantity | 880 kits |
| Distribution | USA only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.