[pending] MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C H
Pending LLM rewrite. Source: FDA_DEVICE Z-2505-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
The recalled product
- Product
- MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN PACK, FS LAP TUBAL LIGATION, HILLSDALE D&C / HYSTEROSCOPY, LAVH NEW BRAUNFELS,TVH PACK, etc (see recall documents for a full list of affected products)
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
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)
- Medline Kit Number/SKU DYNJ61063A: UDI/DI 10193489640458 (each)
- 40193489640459 (case)
- Lot Number 21KBV571
- Medline Kit Number/SKU DYNJ61063B: UDI/DI 10195327193478 (each)
- 40195327193479 (case)
- Lot Number 23EBU351
- Lot Number 23DBQ190
- Lot Number 23BBE364
- Lot Number 22IBW094
- Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each)
- 40195327451685 (case)
- Lot Number 26CMK666
- Lot Number 26BMG709
- Lot Number 26AMI644
- Lot Number 25KMD133
- Lot Number 25JMA568
- Lot Number 25IMF717
- Lot Number 25HMJ595
- Lot Number 25FMH149
- Lot Number 25EME964
Distribution
Distributed nationwide across the United States.
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