IR Procedure Pack, CEAT19W; Medical convenience kit
Reported: October 2, 2024 Initiated: August 7, 2024 #Z-3235-2024
Product Description
IR Procedure Pack, CEAT19W; Medical convenience kit
Reason for Recall
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Details
- Recalling Firm
- American Contract Systems, Inc.
- Units Affected
- 1 unit
- Distribution
- US Nationwide distribution in the states of MO, MN, MA, OH, NE.
- Location
- Kansas City, MO
Frequently Asked Questions
What product was recalled? ▼
IR Procedure Pack, CEAT19W; Medical convenience kit. Recalled by American Contract Systems, Inc.. Units affected: 1 unit.
Why was this product recalled? ▼
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 2, 2024. Severity: Moderate. Recall number: Z-3235-2024.
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