Medline Medical Procedure Convenience Kits Recalled for Sterility Risk
Medline is recalling specific medical procedure convenience kits because a packaging defect could allow the use of non-sterile products if the vendor seal is opened.
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: The recall involves a risk-of-harm product (medical device) where the potential for using non-sterile product could lead to infection, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Medline Industries, LP is recalling specific medical procedure convenience kits, including various OB and D&C packs, due to a potential sterility risk. The recall involves 1,506 units of these kits that were packaged in breather pouches from lot 323080002. The affected products were distributed nationwide in the United States, as well as in Canada and Panama.
The recall was initiated because the packaging may allow for the potential use of non-sterile product if the vendor seal of the pouch is opened or unsealed. This defect poses a risk to patient safety by compromising the sterile environment required for medical procedures.
Healthcare facilities and consumers who have these specific kits should check their inventory for the affected lot number and reference numbers listed in the recall notice. If the products are found, they should be removed from use and returned to Medline Industries, LP for further instructions.
The recalled product
- Product
- Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF, REF DYNJ0912449M; b) OB PACK, REF DYNJ17309G; c) OB PK, REF DYNJ34268D; d) OB DELIVERY PACK, REF DYNJ34274B; e) OB DELIVERY PACK, REF DYNJ34274B; f) D AND C PACK, REF DYNJ39668I; g) OB…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Affected units
- 1,506
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) REF DYNJ0912449M
- UDI/DI 40889942437536 (each)
- 10889942437535 (case)
- Lot Numbers: 23LBP185
- b) REF DYNJ17309G
- UDI/DI 40193489277181 (each)
- 10193489277180 (case)
- Lot Numbers: 24ABB399
- c) REF DYNJ34268D
- UDI/DI 40193489821421 (each)
- 10193489821420 (case)
- Lot Numbers: 23LBM844
- d) REF DYNJ34274B
- UDI/DI 40889942642244 (each)
- 10889942642243 (case)
- Lot Numbers: 23LBS099
- e) REF DYNJ34274B
- Lot Numbers: 23KBB869
- f) REF DYNJ39668I
- UDI/DI 40195327456284 (each)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 33 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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