Integra LifeSciences Corporation: Medical Device Recall in 2013 - (Recall #: Z-1288-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

Product Classification:

Class II

Date Initiated: March 28, 2013

Date Posted: May 22, 2013

Recall Number: Z-1288-2013

Event ID: 64778

Reason for Recall:

Due 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.

Status: Terminated

Product Quantity: 17, 616 boxes

Code Information:

1105177, 1105178 1110143, 1110227 1110228, 1110229 1110230, 1110233 1110786, 1110787 1111356, 1105179 111023 1, 1110232 1110785

Distribution Pattern:

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

Voluntary or Mandated:

Voluntary: Firm initiated