CLASS II Device recall · Reported 27 Jun 2012 · FDA Enforcement Report
Heparin Lock Flush Solution recalled by App Pharmaceuticals
App Pharmaceuticals is recalling Heparin Lock Flush Solution, USP, 100 USP Units/mL Multiple Dose Vial, plastic vial, vial, distributed nationwide in the US. The recall was initiated on 20 May 2010 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1825-2012
- FDA event ID
- 57878
- Recalling firm
- App Pharmaceuticals, Schaumburg, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 May 2010
- FDA classified
- 19 Jun 2012
- Reported
- 27 Jun 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 20 May 2010 | Recall initiated by company | |
| 19 Jun 2012 | Classified by FDA | +761 days |
| 27 Jun 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Incomplete documentation associated with test results.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, NDC 63323-545-05, Product Code 504505; Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
Where it was distributed
Nationwide Distribution and Puerto Rico
Questions about this recall
Is Heparin Lock Flush Solution, USP, 100 USP Units/mL Multiple Dose Vial, plastic vial, vial recalled?
Yes. App Pharmaceuticals recalled Heparin Lock Flush Solution, USP, 100 USP Units/mL Multiple Dose Vial, plastic vial, vial on 20 May 2010. The recall is Class II and its status is Terminated. Recall number Z-1825-2012.
Why was it recalled?
CGMP Deviations: Incomplete documentation associated with test results.
Which lots are affected?
Product Code 504501 (1 mL): Lot 406912 (Expiration Date 01/11) and Lot 408072 (Expiration Date 09/11); Product Code 504505 (5 mL): Lot 406914 (Expiration Date 01/12)
Where was it sold?
Nationwide Distribution and Puerto Rico
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from App Pharmaceuticals
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Heparin Lock Flush Solution recalled by App Pharmaceuticals | App Pharmaceuticals | Foreign Material | Nationwide |
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