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Z-3172-2011

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

Medela AG / initiated 2011-07-27 / Terminated / root cause: labeling and UDI
FDA source (opens on fda.gov)

Medela Inc began a recall of Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061. Medela Healthcare, McHenry, IL 60051; A Wound Drain Kit containing a 10 mm Flat Drain... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-3172-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medela AG
Product
Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061. Medela Healthcare, McHenry, IL 60051; A Wound Drain Kit containing a 10 mm Flat Drain, antimicrobial gauze pad, non-adherent wound contact layer, transparent dressing, tubing clamp, barrier film wipe, adhesive tape, sterile saline, and suction extension tubing; 15 individually bagged kits per case; Some of the kits were mislabeled as Invia Wound Therapy Tier III Wound Dressing Kit, 15 Fr Round Channel Drain, product 0877067, lot 370118
Product code
MCY Wound Dressing Kit
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".
Root cause tag
labeling and UDI
FDA root cause
Error in labeling
Action
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 [email protected], 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 [email protected].
Quantity in commerce
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, Pennsylvania, South Carolina, Tennessee and Texas.
Product codes and lots
product code 0877061, lot 370118, some of which were mislabeled as product 0877067, lot 370118