Recall Z-0749-2021— Merit Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2020-11-10, terminated 2022-10-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL), scalpel, several syringes, table covers, stopcocks, inflation device, and gauze. Reason: Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which may lead to an infection requiring medical treatment..
- Recalling firm
- Merit Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-10
- Terminated
- 2022-10-05
- Firm location
- South Jordan, UT, United States
Product description
Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL), scalpel, several syringes, table covers, stopcocks, inflation device, and gauze
Reason for recall
Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which may lead to an infection requiring medical treatment.
Data sourced from openFDA. This site is unofficial and independent of the FDA.