Integra Epidural Anesthesia Kits Recalled Due to Syringe Plunger Defect
Integra LifeSciences is recalling specific lots of epidural anesthesia kits because the included BD LOR syringe plunger may stall or stick.
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 defect where a syringe plunger may stall or stick, posing a risk of harm to patients during a medical procedure. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration. The recall is being conducted in response to a Product Advisory Notice from BD Medical regarding the LOR syringes included in these kits.
The identified issue is that the plunger of the syringe may stall or stick when traveling within the syringe. These kits are intended to provide licensed medical professionals with a kit containing drugs and other medical devices used to support the administration of general, local, or spinal anesthetics. The BD LOR syringe is specifically intended for use in conjunction with an epidural needle to verify needle tip placement in the epidural space using the Loss of Resistance Technique. The LOR Syringe is not intended for injection or aspiration.
The recall affects 359,250 units that were distributed nationwide in the United States and to one foreign consignee in Mursalat. The source text does not specify the actions consumers or medical professionals should take, nor does it report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are…
- Affected units
- 359,250
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)
- Kit Cat No: 10-2433
- 13-2595
- 13-2616
- 13-2628
- 3104195
- 3403061
- 3403150
- 3403316
- 3403579
- 3403727
- 3403776
- 3403813
- 3403989
- 3404131
- 3404269
- 3404293
- 3404417
- 3404468
- 3404578
- 3503559
Distribution
Distributed nationwide across the United States.
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