Integra Recalls INSTAT Hemostatic Agent Due to Pyrogen Levels
Integra LifeSciences is recalling INSTAT absorbable hemostatic agent because process deviations may have resulted in higher pyrogen levels than permitted.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (pyrogens) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Integra LifeSciences Corporation is recalling 17,616 boxes of INSTAT - Agent, Absorbable Hemostatic, Collagen Based. The recall is due to a process deviation that may have caused the product lots to be released with higher levels of pyrogens than permitted by the product specifications.
INSTAT MCH is recommended for use in surgical procedures, excluding urological and ophthalmological surgery, as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. The affected product was distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as countries in the Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
Healthcare providers and patients should stop using the affected lots and contact Integra LifeSciences Corporation for further instructions. The specific lot codes involved in the recall are 1105177, 1105178, 1110143, 1110227, 1110228, 1110229, 1110230, 1110233, 1110786, 1110787, 1111356, 1105179, 1110231, 1110232, and 1110785.
The recalled product
- Product
- 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…
- Manufacturer
- Integra LifeSciences Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 1105177
- 1105178 1110143
- 1110227 1110228
- 1110229 1110230
- 1110233 1110786
- 1110787 1111356
- 1105179 111023 1
- 1110232 1110785
Distribution
Part of a larger recall action
This product is one of 21 recalled by Integra LifeSciences Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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