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Bifurcated Needles for Allergy Skin Testing
ROECHLING MEDICAL LANCASTER, LLC · Model PB-02000-000-00 · UDI-DI 10868652000208
1
510(k) clearances
3
Adverse events
3
Recalls
6
Facilities
Description
Bifurcated Needles for Allergy Skin Testing
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-03-22 | Medscience Inc | During an FDA inspection it was found that the products are marketed without a cleared 510k. |
| 2015-02-03 | Allergy Laboratories, Inc. | Potential for glass particles within the vials |
| 2006-04-20 | Hollister Stier Laboratories LLC | Potential for vials to be cracked at the vial stopper interface. This could compromise the sterility of the products compounded into the vials. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.