FDA Recall Terminated

Rigid Suction Canister 3000 CC and 2000 CC.

Recall: Z-0352-2017 · Initiated August 10, 2016

Recall

Recall Number
Z-0352-2017
Event Number
75128
Firm
Medline Industries Inc
FEI Number
1417592
Product Code
KDQ
Status
Terminated
Root Cause
Process control
Initiated
August 10, 2016
Terminated
June 3, 2019
Address
1 Medline Pl, Mundelein, IL, 60060-4485

Description

Rigid Suction Canister 3000 CC and 2000 CC.

Reason

Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure during use.

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.

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.

Quantity

7,680 units