Recall Z-0827-2008 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
AM2 PAT INC
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium Chloride 120/Case, Catalog #1003-01, NDC #64054-1003-01, 3 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501.
| Date | Jan 30, 2008 (initiated Dec 11, 2007) |
| Status | Terminated |
| Reason | Lack of assurance of sterility by manufacturer |
| Root cause | Process design |
| Action | AM2PAT contacted their distributors by phone on or about January 17, 2008 and instructed them to stop distribution of their pre-filled syringes and to contact their customers to recall all AM2PAT manufactured lots and all sizes of prefilled, Heparin Lock Flush syringes and Normal Saline IV Flush syringes (B Braun and Sierra Brands) to the consumer level. A press release was issued on January 17, 2008. The firm had eariler on 12/20/2007 recalled a single lot of Heparin syringes, the January extension was to all lots/all sizes of its Heparin and Saline syringes. |
| Quantity | 618 cases, 120 syringes per case |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032417 | HEPARIN LOCK FLUSH SYRINGE Am2 Pat, Inc., Dec 23, 2003 |