Kardium Recalls TORQ Sternal Closure Devices Due to Metal Part Risk
Kardium is recalling 480 units of the TORQ Sternal Closure Device because a metal part may dislodge during use.
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 risk-of-harm product where a metal part may dislodge during surgery, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Kardium is recalling 480 units of the TORQ Sternal Closure Device, model TQ01A, Lot 062711. The recall is due to a probability that one of the metal parts may be dislodged during use. The device is a disposable, single-use, non-implantable tool used during cardiac surgery to tension and twist standard stainless steel surgical sutures for sternal closure.
The affected units were distributed nationwide, including the states of Florida, Georgia, Illinois, and New Hampshire. The devices are supplied sterile in shelf boxes containing 10 devices each, which are shipped in cartons containing either one or six shelf boxes. The expiry date for the recalled lot is June 2014.
Healthcare facilities and consumers should stop using the affected devices immediately. Users should contact Kardium for further instructions on how to return or dispose of the product.
The recalled product
- Product
- TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A. The Catalog numbers are: 17-00001: TORQ Sternal Closure Device Shipping Carton (6-10 packs), Sterile and, 15-00001 (or 17-00002): TORQ Sternal Closure Device 10-pack - Sterile.…
- Manufacturer
- Kardium
- Hazard
- Affected units
- 480
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 (1)
- Lot No. 062711. Expiry date is June 2014.
Distribution
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