Medline medical procedure kits recalled for potential needle guide ring detachment
Medline is recalling 12,994 paracervical and pudendal procedure kits because the Trumpet Needle Guide ring can detach when excessive pressure is applied, potentially causing injury.
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: This is an FDA Class II recall for a device component that can detach during use, creating a risk of injury. No illnesses or injuries have been reported in the source text. Per the rubric, a risk-of-harm defect without reported injuries scores as High (3).
Plain-English summary
Medline Industries, LP is recalling medical procedure kits used for paracervical and pudendal procedures. The recall affects 12,994 units of four kit models: PARACERVICAL PUD TRAY (REF DYNDH1832), AHS PARACERVICAL/PUDENDAL KIT (REF DYNJRA2210), PARACERVICAL/PUDENDAL BLK KIT (REF DYNJRA9046), and PARACERVICAL/PUDENDAL BLK KIT (REF DYNJRA9046H). These products were distributed nationwide in the United States.
The Trumpet Needle Guide ring component on these kits can detach when excessive pressure is applied. This defect could occur during use of the procedure kits and may result in injury.
The recalled product
- Product
- Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PUDENDAL KIT, REF DYNJRA2210; c) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046; d) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046H; Medical procedure…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedure Kit
- Affected units
- 12,994
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)
- a) DYNDH1832: UDI/DI 40195327330713 (case)
- 10195327330712 (unit)
- Lot Numbers: 23KBI682
- 23KBT359
- 23KBX629
- b) DYNJRA2210: UDI/DI 40195327424047 (case)
- 10195327424046 (unit)
- Lot Numbers: 23JBX245
- 23LBN930
- c) DYNJRA9046: UDI/DI 40195327338610 (case)
- 10195327338619 (unit)
- Lot Numbers: 23JBX367
- 23JBX368
- 23JBX369
- 23JBX370
- 23LBA896
- 23LBH751
- 23LBL612
- 23LBV325
- 23LBV326
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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