Z-0352-2017Class II

Rigid Suction Canister 3000 CC and 2000 CC

Name: Z-0352-2017 Rigid Suction Canister 3000 CC and 2000 CC
Creator: Medline Industries Inc
Published: 2016-08-10
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2016-08-10 / Terminated / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of Rigid Suction Canister 3000 CC and 2000 CC on 2016-08-10. FDA classified it as Class II and gives the reason as "Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0352-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-10
Posted: 2016-11-03
Terminated: 2019-06-03
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Rigid Suction Canister 3000 CC and 2000 CC.
Product code: KDQ Bottle, Collection, Vacuum
Reason for recall: Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure during use.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medline Industries, Inc. sent an Urgent Recall Immediate Action Required letter dated August, 23, 2016, and destruction form via first class mail to affected customers on August 17, 2016 and August 23, 2016. The firm recommended the following actions: REQUIRED ACTION: 1. Immediately check your stock for item number OR220 and OR230 with lot numbers beginning with 9961601xxxx through 9961604xxxx (listed on the original case packaging). Destroy all affected products. If the rigid canisters are NOT in the original case packaging, we are instructing you to destroy them and we will send replacements. 2.Please return the completed enclosed destruction form listing the quantity of product(s) destroyed. Even if you do not have any of this product please complete and return the form, as indicated on the destruction form. When we receive your completed destruction form your account will receive replacements. 3.If you are a distributor, promptly notify any of your customers that may have received affected product. If you have any questions, please contact 866-359-1704.
Quantity in commerce: 7,680 units
Distribution: 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.
Product codes and lots: RIGID CANISTER 2000 cc and 3000 cc with product code OR220 and OR230. Affected Lot Numbers 9961601xxxx through 9961604xxxx

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0352-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0352-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-03

Product code KDQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)