Paracentesis Tray with Lidocaine Recalled for Temperature Abuse
McKesson Medical-Surgical is recalling Paracentesis/Thoracentesis Trays that were subjected to temperature abuse during distribution, which may compromise the sterility and efficacy of the included Lidocaine Hydrochloride. No illnesses have been reported.
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: FDA Class II recall involving temperature abuse of a pharmaceutical product that may compromise sterility and efficacy. This fits the rubric criterion of 'risk-of-harm products where injury has not yet been reported,' since no illnesses or injuries are documented.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Paracentesis/Thoracentesis Trays (10 units per case) containing Lidocaine Hydrochloride USP 1%, 5mL manufactured by Becton Dickinson. These prescription-only trays are used in medical procedures including paracentesis and thoracentesis.
The recall is due to Current Good Manufacturing Practices (cGMP) deviations involving temperature abuse during product distribution. Temperature exposure outside acceptable ranges may compromise the sterility and efficacy of the Lidocaine component.
The affected product was distributed nationwide across the United States. Approximately 5 cases of the recalled product were distributed. The manufacturer was unable to identify specific lot numbers for individual customers; notification letters specify the distribution dates for potentially affected shipments.
Healthcare providers and patients who have received this product should not use it and should contact McKesson Medical-Surgical Inc. for instructions on proper disposition. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Paracentesis/Thoracentises Tray (10/cs) Rx CRFPED, Lidocaine Hydrochloride USP, 1%, 5mL, Rx only, MFG: Becton Dickinson
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Procedural Tray
- Hazard
- temperature-abuse
- sterility-compromise
Distribution
Distributed nationwide across the United States.
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