Rigid Suction Canister 3000 CC and 2000 CC.
FDA Recall Z-0352-2017 · Posted None
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Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeKDQ
Date Initiated2016-08-10
Date Terminated2019-06-03
Product Quantity7,680 units
Reason for Recall
Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure during use.
Firm 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.
Root Cause
Process control
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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