Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters
FDA device recall Z-1989-2016 · posted 2016-06-14 · Terminated
Recall details
- Recalling firm
- Excelsior Medical Corp
- Reason for recall
- Certain lots of Heparin Lock Flush, USP Syringes (5 ml Fill in 10 ml Syringe) failed Anti-Factor IIa assay for potency during testing of retention samples for heparin potency.
- Action taken
- Excelsior Medical Inc. sent a recall letter on 4/29/2016 via certified mail. Customers are instructed to discontinue using the product subject to this recall. Customers are requested to complete the customer reply form and fax it (866) 807-3714, so arrangements can be made to return the product to Excelsior.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NZW
- Quantity affected
- 184,500
- Distribution
- US Nationwide distribution.
- Date initiated
- 2016-04-28
- Date posted
- 2016-06-14
- Date terminated
- 2017-08-08
- Location
- Neptune, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYREX PRE-FILLED SYRINGE (K023740) | Excelsior Medical Corp. | 2003-05-13 |