Z-0352-2017 Class II Terminated
FDA device recall Z-0352-2017 was initiated by Medline Industries Inc on Aug 10, 2016 and is designated Class II. Reason for recall: Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure during use. The recall status is terminated (terminated Jun 3, 2019). Affected quantity: 7,680 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 9, 2016
- Initiation Date
- Aug 10, 2016
- Termination Date
- Jun 3, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,680 units
Product Description
Rigid Suction Canister 3000 CC and 2000 CC.
Reason for Recall
Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure during use.
Distribution Pattern
US Distribution to the following states: CA , CO , FL , GA, GA , IL , MA, MA , MD , MI, MO , NC , NE , NJ , NY, NY , OH, OK , PA, TX and WA.
Code Information
RIGID CANISTER 2000 cc and 3000 cc with product code OR220 and OR230. Affected Lot Numbers 9961601xxxx through 9961604xxxx
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0352-2017
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026