Medline oral restoration kits contain catheters failing performance specifications
Medline Oral Restoration procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications.
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 the Oral Restoration medical procedure kit, kit number/SKU DYNJ86253A.
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.
Affected product is UDI/DI 10198459556654 for the each and 40198459556655 for the case, lot numbers 25KBC063 and 25JBO955. Distribution was worldwide, including nationwide in the United States.
Facilities should identify affected stock using the kit number, UDI codes and lot numbers above, quarantine it, and follow the instructions issued by Medline.
The recalled product
- Product
- MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253A
- Manufacturer
- Medline Industries, LP
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 10198459556654 (each)
- 40198459556655 (case). Lot Numbers: 25KBC063
- 25JBO955.
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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