Z-2466-2020 Class II Terminated
FDA device recall Z-2466-2020 was initiated by ROi CPS LLC on May 19, 2020 and is designated Class II. Reason for recall: Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire… The recall status is terminated (terminated September 1, 2020). Affected quantity: 200 kits.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2020
- Initiation Date
- May 19, 2020
- Termination Date
- September 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200 kits
Product Description
Respirator Crash Cart Kit
Reason for Recall
Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits.
Distribution Pattern
Domestic distribution only to: MO and LA.
Code Information
Item #: 830066; Lot #: 77127, 74813 and 63168 Expiration date per lot: Lot: 77127, Exp date: 1/31/2021 Lot: 74813, Exp date: 8/30/2021 Lot: 63168, Exp date: 1/30/2021