Device recall: MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
Class II FDA enforcement event 92486. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Class II, in the words of FDA
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
MEDLINE INDUSTRIES, LP - Northfield started this device recall on 18 May 2023. The firm address in the FDA record is in Northfield, IL. FDA put the recall in Class II. FDA event 92486 has 7 product records. The first FDA enforcement report date is 19 Jul 2023. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution - US Nationwide and the country of Panama.
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
7 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2131-2023 | MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A | 183240 units | Class II | Ongoing | 19 Jul 2023 |
| Z-2132-2023 | MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number CDS980089O | 15 units | Class II | Ongoing | 19 Jul 2023 |
| Z-2133-2023 | MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A | 144 units | Class II | Ongoing | 19 Jul 2023 |
| Z-2134-2023 | MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L | 128 units | Class II | Ongoing | 19 Jul 2023 |
| Z-2135-2023 | MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A | 60 units | Class II | Ongoing | 19 Jul 2023 |
| Z-2136-2023 | MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PACK, Model Number VAL050EEPKB | 1500 units | Class II | Ongoing | 19 Jul 2023 |
| Z-2137-2023 | MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I; d) BSHR TOTAL KNEE-LF, Model Number DYNJ24525K; e) BSHR TOTAL HIP-LF, Model Number DYNJ24526P; f) TOTAL KNEE ARTHROPLASTY PACK,… | 4500 units | Class II | Ongoing | 19 Jul 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 7Median of the firm: 2
- Events of the firm on the register
- 120
Other events of the firm
Official channels
- FDA enforcement report Z-2131-2023The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 92486. https://recallregister.com/fda/ii/92486/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution - US Nationwide and the country of Panama.
- What quantity of product is in FDA event 92486?
- The event has 7 product records. The first record gives this quantity:
183240 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.