Medline blood culture kits contain ChloraPrep applicators with open seals
Medline blood culture convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 15,700 units affected.
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: Risk-of-harm product: a breach of sterility on a skin antiseptic applicator used before blood culture collection, with no infection reported in the source.
Plain-English summary
Medline Convenience Kits containing BD ChloraPrep Clear - 1 mL Applicator are being recalled across three labels: BLOOD CULTURE KIT (REF DYNDH1462B), BLOOD CULTURE KIT (REF DYNDH1622C) and BLOOD CULTR KT DIVRSN DEVICE (REF DYNDH1866). The action covers 15,700 units across the lot numbers listed in the recall notice.
According to the notice, the affected convenience kits contain BD ChloraPrep Clear 1 mL Applicators which were recalled by BD due to the potential to exhibit an open seal on the packaging. The notice states this may constitute a breach to sterility, which may in turn lead to infection related harms for the patient. The FDA classified the action as Class II. The source does not report any infection having occurred.
Distribution was domestic, to California, Florida, Pennsylvania and Texas, with no international distribution. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the REF numbers, UDI/DI codes and lot numbers in the recall notice and follow the instructions issued by Medline.
The recalled product
- Product
- Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOOD CULTURE KIT, REF DYNDH1622C; 3) BLOOD CULTR KT DIVRSN DEVICE, REF DYNDH1866.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Convenience kit
- Affected units
- 15,700
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 (11)
- 1) REF DYNDH1462B: UDI/DI 10195327662462 (EA)
- 40195327662463 (CASE)
- Lot Numbers: 24EBU164
- 24FBD281
- 24FBK195
- 2) REF DYNDH1622C: UDI/DI 10195327509873 (EA)
- 40195327509874 (CASE)
- Lot Numbers: 24EBU004
- 3) REF DYNDH1866: UDI/DI 10195327400958 (EA)
- 40195327400959 (CASE)
- Lot Numbers: 24EBT285.
Distribution
Part of a larger recall action
This product is one of 4 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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