Recalls / —
—#126504
Product
Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case. Packaged by Medline Industries Inc. This product is used as an elastic bandage to support and compress a part of a patient's body. It is also used as a tourniquet to restrict blood flow to a part of a patient's body.
- FDA product code
- FQM — Bandage, Elastic
- Device class
- Class 1
- Medical specialty
- General Hospital
- Affected lot / code info
- Product Number: DYNJ05116A . Lot Number: 13LA1009.
Why it was recalled
This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile.
Root cause (FDA determination)
Employee error
Action the firm took
Medline Industries issued an Immediate Action Required letter dated March 20, 2014 to all affected customers. The letters included instructions to: 1) immediately check inventories for the recalled products and quarantine the recalled products; 2) complete and return the enclosed destruction form listing the quantity of destroyed product (credit will only be issued if the completed form is received); and 3) If the customer is a distributor, promptly notify the distributor's customers that may have received the recalled products about this recall. Direct accounts and their customers that have any questions can contact Medline Industries at 866-359-1704.
Recalling firm
- Firm
- Medline Industries Inc
- Address
- 1 Medline Pl, Mundelein, Illinois 60060-4485
Distribution
- Distribution pattern
- Nationwide Distribution including AZ, CA, IA, IL, IN, KY, LA, MI, MS, NJ, NY, OH, PA, TX, and WA.
Timeline
- Recall initiated
- 2014-03-20
- Posted by FDA
- 2014-05-21
- Terminated
- 2017-11-29
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #126504. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.