Medline gynaecology procedure packs contain catheters failing performance specifications
Medline gynaecology procedure packs including hysteroscopy, D&C and tubal ligation kits are being recalled because sample catheters did not meet performance specifications. 37,324 units affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall where a catheter connector can detach in use and dimensions fall out of specification, a risk of harm with no injuries reported.
Plain-English summary
Medline Industries, LP is recalling 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 and TVH Pack, among the products listed in the recall documents. The action covers 37,324 units.
During an internal review, Medline identified that representative samples did not meet applicable performance specifications. According to the firm, the 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 FDA classified the action as Class II.
Distribution was worldwide, including nationwide in the United States. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the kit numbers, UDI codes and lot numbers in the recall notice, quarantine it, and follow the instructions issued by Medline.
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
- Affected units
- 37,324
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
Part of a larger recall action
This product is one of 30 recalled by Medline Industries, LP 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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