Recall Z-0898-2022 ยท NGT Saline, Vascular Access Flush
MEDLINE INDUSTRIES, LP - Northfield
Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.
| Date | Mar 4, 2022 |
| Status | Terminated |
| Reason | Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field. |
| Root cause | Material/Component Contamination |
| Action | The recalling firm issued letters dated 3/4/2022 via regular mail informing the customer there was a sterility failure of the exterior of the syringe and in the event a syringe from the affected lot was placed on a sterile field, the sterile field may become compromised. The required actions were to immediately check their stock for the affected lot number, quarantine it, and then destroy it. The enclosed destruction form was to be completed listing the quantity of affected product destroyed, and once the form was returned, they would receive credit. If the product has been transferred to a |
| Quantity | 7,800 pouched syringes |
| Distribution | US Nationwide Distribution was made to KY, OK, and TX. There was no foreign/government/military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082837 | STERILE FIELD SALINE PRE-FILLED SYRINGE(S) Excelsior Medical Corp., Dec 18, 2008 |