The Recall Desk
ModerateFDA (Devices)·Z-2424-2015·Announced 2015-08-26

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.

What this means for you

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.
Category
Medical Device — Surgical Instruments
Hazard
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

Same manufacturer · International Biophysics Corp.

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Same hazard · packaging integrity

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