Z-2632-2017 Class II Terminated
FDA device recall Z-2632-2017 was initiated by 3M Company - Health Care Business on May 22, 2017 and is designated Class II. Reason for recall: It was discovered that one Ranger Pressure lnfusor Model 145, SN: 100873, produced a left chamber pressure that was slightly below the manufacturing specification. The recall status is terminated (terminated June 14, 2018). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2017
- Initiation Date
- May 22, 2017
- Termination Date
- June 14, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required.
Reason for Recall
It was discovered that one Ranger Pressure lnfusor Model 145, SN: 100873, produced a left chamber pressure that was slightly below the manufacturing specification.
Distribution Pattern
U.S. Distribution: TX only
Code Information
Serial Number: 100873