Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061. Medela Healthcare, McHenry, IL 60051; A Wound Drain

FDA device recall Z-3172-2011 · posted 2011-09-08 · Terminated

Recall details

Recalling firm

Medela Inc

Reason for recall

Medela determined that some of the individual kits or bags of lot #370118 of "0877061 Wound Dressing Set, Tier I, 10 MM Flat Drain", were labeled incorrectly as "0877067 Wound Dressing Set, Tier III 15 Fr Round Channel Drain". The outside label on the case is correctly labeled as "0877061 Wound Dressing Set, Tier 1,10 MM Flat Drain".

Action taken

Medela Inc. sent an "Urgent Device Recall" letter dated July 26, 2011 to all affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) not to use the affected lot and place them in quarantine 2) stop sale and distribution and set aside their existing inventory of the affected product 3) conduct a physical count and record the data on the Product Inventory Form included with this letter 4) complete and return the Product Inventory Form via fax to 800-995-7867 or e-mail suction@medela.com, even if they have no affected product on hand 5)if they have the affected product in stock, Medela Customer Service will ship substitute product to the customer at no cost. 6) and to record the number of units on hand for return and replacement on the enclosed Product Inventory Form. The completed form should be returned via fax or e-mail to Medela even if the account has no inventory of the affected lots. If you have any questions about this recall please call (877) 735-1626 or e-mail at suction@medela.com.

Root cause

Error in labeling

Status

Terminated

Product code

MCY

Quantity affected

3,000 kits

Distribution

Nationwide Distribution including the states of California, Florida, Georgia, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Mississippi, New Jersey, New Mexico, North Carolina, Ohio, Pennsylvan

Date initiated

2011-07-27

Date posted

2011-09-08

Date terminated

2012-02-16

Location

Mchenry, IL

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