Halyard CPT Cardiac Cath Pack Recalled Due to Loose Metal Flakes in Forceps and Clamps
AVID Medical is recalling Halyard CPT Cardiac Cath Pack convenience kits due to small metal flakes that may detach from sponge forceps and towel clamps. Metal flakes could enter a surgical site undetected and cause local or foreign body reactions.
What this means for you
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: This is a Class II FDA medical device recall with no reported illnesses or injuries. The hazard is potential rather than demonstrated—metal flakes may detach and enter a surgical site undetected. Per the severity rubric, risk-of-harm products where injury has not yet been reported are scored High (3).
Plain-English summary
AVID Medical, Inc. is recalling Halyard CPT CARDIAC CATH PACK Model SHAN430-02 convenience kits distributed nationwide. The recall covers 288 units with lot numbers 1600943, 1600944, and 1600945.
These kits contain sponge forceps and towel clamps that may shed small metal flakes. The metal flakes could potentially detach and enter a patient's surgical site during a procedure without being detected. If this occurs, patients may experience local reactions or retained foreign body material.
Patients and healthcare facilities should be aware of this recall. For information about how to obtain replacement products or proper disposition of affected inventory, contact the recalling manufacturer AVID Medical, Inc.
The recalled product
- Product
- Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02
- Manufacturer
- AVID Medical, Inc.
- Hazard
- foreign-body
- surgical-contamination
- component-failure
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 (3)
- GTIN: 10809160371800 Lot Number: 1600943
- 1600944
- 1600945
Distribution
Distributed nationwide across the United States.
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