Bayer Recalls Medrad Source Administration Sets for Dosing Errors
Bayer Healthcare is recalling Medrad Source Administration Sets because tubing defects may cause incorrect dose positioning during nuclear medicine procedures.
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: The recall is classified as FDA Class II. The hazard involves potential dosing errors in medical procedures, which is a risk-of-harm product issue where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Bayer Healthcare is recalling Medrad Source Administration Sets (Catalog number INT CSS) used with MEDRAD Intego PET Infusion pump Systems. These devices are utilized in nuclear medicine diagnostic procedures.
The recall is due to an investigation finding that the inner diameter of the saline tubing is out of specification. This defect may cause the system to fail to position the dose correctly during extraction, potentially leading to a low measurement of the extracted dose or a higher dose being extracted. Additionally, occluded tubing may impair the priming function and prompt a prime fail error.
The affected units were distributed nationwide to specific states including AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MI, MN, MO, NC, NE, NH, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, and WI. Users should stop using the affected administration sets and contact Bayer Healthcare for further instructions.
The recalled product
- Product
- Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures.
- Manufacturer
- Bayer Healthcare
- Affected units
- 198,598
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)
- 50856405
- 50857510
- 50860994
- 50866789
- 50867921
- 50869464
- 50869465
- 50871131
- 50872965
- 50878229
- 50878230
- 50878231
- 50878232
- 50881328
- 50881393
- 50881394
- 50881395
- 50881506
- 50881511
- 50881512
Distribution
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