Home › NEOMEND, INC. › Progel
Progel
NEOMEND, INC. · Model PGEN005-06 · UDI-DI 00801741010002
NBE
Prescription
0
510(k) clearances
330
Adverse events (14 deaths)
11
Recalls
15
Facilities
Description
Progel, Pleural Air Leak Sealant, Extended Applicator Spray Tip, 16 cm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-06 | Baxter Healthcare Corporation | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the produ |
| 2023-12-06 | Baxter Healthcare Corporation | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the produ |
| 2016-05-12 | Baxter Healthcare Corp | Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation |
| 2016-05-12 | Baxter Healthcare Corp | Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation |
| 2016-05-12 | Baxter Healthcare Corp | Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation |
| 2014-10-17 | Mallinckrodt Manufacturing LLC | Product was improperly labeled leading to improper storage. |
| 2012-08-13 | Neomend Inc | Product was distributed with an incorrect expiration date. Product was labeled with an expiration date of 2013-04 and should have been labeled with 2012-09. |
| 2011-07-28 | Baxter Healthcare Services L.P. | The recall is being conducted as a precautionary measure due to out of specification results observed at the 24 months time point (out of 24-month licensed shelf life to expiration |
| 2010-01-14 | Baxter Bioscience | The recall is being conducted as a precautionary measure due to out of specification results at the 18 month and 21 month time points (out of the 24 month licensed shelf life to ex |
| 2010-01-14 | Baxter Bioscience | The recall is being conducted as a precautionary measure due to out of specification results at the 18 month and 21 month time points (out of the 24 month licensed shelf life to ex |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.