Medline C-section prep kits contain ChloraPrep applicators with open seals
Medline C-SECTION PREP convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 48 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, which the notice links to infection related harms, with no infection reported.
Plain-English summary
Medline Convenience Kits containing BD ChloraPrep Clear - 1 mL Applicator, labelled C-SECTION PREP, REF DYNJ32702B, are being recalled. The action covers 48 units from lot 24EBR761, UDI/DI 10193489431070 for each unit and 40193489431071 for the case.
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, UDI/DI codes and lot number above and follow the instructions issued by Medline.
The recalled product
- Product
- Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Convenience kit
- Affected units
- 48
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 (3)
- UDI/DI 10193489431070 (EA)
- 40193489431071 (CASE)
- Lot Numbers: 24EBR761
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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