Medline Blood Culture Kits Recalled for Potential Sterility Breach
Medline is recalling 3,650 blood culture kits nationwide due to potential packaging defects that may compromise sterility and expose patients to microbial contamination.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that potential health consequences include hospitalization and that severe infection could become life-threatening in rare cases, meeting the rubric criteria for a Severe (4) rating.
Plain-English summary
Medline Industries, LP is recalling 3,650 units of two blood culture kit models: the Blood Culture Tray Pediatric (Model DYNDH1193) and the Blood Culture Kit 2 w/Connect (Model DYNDH1487A). The recall covers kits distributed nationwide in the United States.
The recall is due to a potential breach of sterility in the packaging. Wrinkles in the paper lidding may extend to the seal area, which could compromise the sterile barrier. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination.
Potential health consequences range from no injury to localized infection or more serious infections requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly for critically ill or immunocompromised patients, severe infection could become life-threatening. Consumers and healthcare facilities should check their inventory for the specific lot numbers listed in the recall notice and stop using affected kits.
The recalled product
- Product
- Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2) BLOOD CULTURE KIT 2 W/CONNECT, Model Number: DYNDH1487A
- Manufacturer
- Medline Industries, LP
- Affected units
- 3,650
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 (20)
- 1) DYNDH1193
- UDI-DI: 10889942499953(each)
- 40889942499954(case)
- Lot Number: 24ABA808
- 2) DYNDH1193
- Lot Number: 24BBV222
- 3) DYNDH1193
- Lot Number: 24GBT333
- 4) DYNDH1193
- Lot Number: 24IBU725
- 5) DYNDH1193
- Lot Number: 23KBX578
- 6) DYNDH1193
- Lot Number: 23LBP536
- 7) DYNDH1487A
- UDI-DI: 10193489484311(each)
- 40193489484312(case)
- Lot Number: 25BMG311
- 8) DYNDH1487A
- Lot Number: 24AME318
Distribution
Distributed nationwide across the United States.
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