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Integra® Miltex® HeliTape®

Integra Lifesciences Corporation · Model 62200 · UDI-DI 10381780000280

LPG Prescription
0
510(k) clearances
24
Adverse events
7
Recalls
6
Facilities

Description

HeliTape ® ABSORBABLE COLLAGEN Wound Dressing, 1in x 3in

Recalls

DateFirmReason
2013-03-28Integra LifeSciences CorporationDue to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
2013-03-28Integra LifeSciences CorporationDue to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
2013-03-28Integra LifeSciences CorporationDue to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
2013-03-28Integra LifeSciences CorporationDue to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
2013-03-28Integra LifeSciences CorporationDue to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
2013-03-28Integra LifeSciences CorporationDue to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
2013-03-28Integra LifeSciences CorporationDue to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

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Data 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.