International Biophysics Corp. Recalls IBC Vascular Loops Due to Seal Issues
International Biophysics Corp. is recalling 771 IBC Vascular Loops because heat seals on sterile pouches may not meet strength 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential failure of sterile packaging integrity without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
International Biophysics Corp. is recalling 771 units of IBC Vascular Loops, catalog numbers CH111 through CH118. These single-use, disposable loops are used in surgical procedures to occlude, retract, and identify arteries, veins, tendons, and nerves.
The recall was initiated because it was discovered that the heat seal placed onto the sterile pouches may not meet strength acceptance criteria. 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 should stop using the affected IBC Vascular Loops and contact International Biophysics Corp. for instructions on return or replacement.
The recalled product
- Product
- IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.
- Manufacturer
- International Biophysics Corp.
- Affected units
- 771
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 (17)
- 031715-3418
- 050815-3513
- 052115-3540
- 033015-3435
- 052115-3542
- 031615-3417
- 050815-3514
- 052115-3543
- 033015-3436
- 050815-3515
- 060915-3578
- 041715-3478
- 033015-3437
- 050815-3516
- 052215-3545
- 042015-3482
- 052115-3541
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
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