Medline Recalls Sterile Syringes Due to Packaging Seal Voids
Medline Industries is recalling 3,690 units of sterile 3mL syringes because voids in the packaging seal caused a loss of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a loss of sterility in a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medline Industries Inc is recalling 3,690 units of Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle (REF DYND3ML21G1A, lot 18JBH655). The recall was initiated because voids were discovered in the Tyvek Form-Fill-Seal packaging seal, resulting in a loss of sterility on the outside of the contents.
The affected syringes were distributed nationwide to facilities in 41 states and the District of Columbia. The specific distribution locations include MA, LA, IL, MO, MI, MN, NJ, KS, GA, NY, PA, SD, CT, TN, MD, OH, VA, FL, TX, KY, CO, IN, AL, CA, MT, OR, AK, DC, IA, ME, NV, NE, SC, WV, WY, RI, NC, AZ, UT, DE, and WI.
Healthcare facilities and consumers should stop using the affected syringes immediately. Users should check their inventory for the specific reference number DYND3ML21G1A and lot number 18JBH655. If these items are found, they should be quarantined and returned to Medline Industries Inc according to the company's instructions.
The recalled product
- Product
- Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153.
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Syringes
- Affected units
- 3,690
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153
Distribution
Part of a larger recall action
This product is one of 3 recalled by Medline Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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