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U.S. Department of Health and Human Services

Class 2 Device Recall Rigid Suction Canister

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  Class 2 Device Recall Rigid Suction Canister see related information
Date Initiated by Firm August 10, 2016
Create Date November 03, 2016
Recall Status1 Terminated 3 on June 03, 2019
Recall Number Z-0352-2017
Recall Event ID 75128
Product Classification Bottle, collection, vacuum - Product Code KDQ
Product Rigid Suction Canister 3000 CC and 2000 CC.
Code Information RIGID CANISTER 2000 cc and 3000 cc with product code OR220 and OR230. Affected Lot Numbers 9961601xxxx through 9961604xxxx
Recalling Firm/
Manufacturer		 Medline Industries Inc
1 Medline Pl
Mundelein IL 60060-4485
Manufacturer Reason
for Recall		 Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure during use.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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