International Biophysics Recalls IBC Aortic Punch Due to Seal Issues
International Biophysics Corp. is recalling 10,330 units of IBC Aortic Punch because the heat seal on sterile pouches may not meet strength acceptance criteria.
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 involves a medical device where a packaging defect (heat seal) may compromise sterility, posing a risk of harm (infection) even though no specific injuries are reported in the source text, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
International Biophysics Corp. is recalling 10,330 units of IBC Aortic Punch. The product is a single-use, disposable surgical punch used to create an opening in the wall of the aorta to prepare a site for anastomosis. The recall covers specific catalog numbers including APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, and APM40.
The recall was initiated because it was discovered that the heat seal placed onto the sterile pouches may not meet strength acceptance criteria. This defect could potentially compromise the sterility of the device. The affected units were distributed worldwide, including the United States, Germany, Norway, Turkey, Chile, Pakistan, and the Republic of South Africa.
Healthcare providers and facilities that have received these products should stop using them and contact International Biophysics Corp. for further instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40 Product Usage: The IBC Aortic Punch is a…
- Manufacturer
- International Biophysics Corp.
- Affected units
- 10,330
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 (20)
- 042415-3488
- 022515-3372
- 02215-3374
- 022515-3371
- 022515-3373
- 022515-3382
- 022515-3383
- 022515-3384
- 022515-3385
- 022515-3386
- 040615-3452
- 040615-3453
- 040615-3449
- 040615-3450
- 040615-3451
- 040615-3448
- 040615-3447
- 050815-3510
- 050815-3509
- 050815-3511
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by International Biophysics Corp. 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.
See all 3 products in this recall →Related recalls
Same manufacturer · International Biophysics Corp.
See all →- ModerateInternational Biophysics Corp. Recalls IBC Vascular Loops Due to Seal Issues
FDA (Devices) · 2015-08-26
- ModerateInternational Biophysics Recalls IBC Suction Wands Due to Seal Defects
FDA (Devices) · 2015-08-26
Same hazard · sterility compromise
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