Device recall: Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for…
Class II FDA enforcement event 89487. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays in treatment due to the need to replace the device or may cause contamination of the fluid path that can lead to bloodstream infection.
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
B. Braun Medical, Inc. started this device recall on 31 Jan 2022. The firm address in the FDA record is in Allentown, PA. FDA put the recall in Class II. FDA event 89487 has 1 product record. The first FDA enforcement report date is 16 Mar 2022. The record gives the status Terminated, with the termination date 29 Apr 2024.
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.
US Nationwide distribution in the states of AZ, CA, FL, LA, MI, MO, MS, NC, NJ, OH, PA, TN, TX, and UT. The country of Canada.
Recalling firm
B. Braun Medical, Inc., Allentown, PA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0727-2022 | Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dose vials. | 15,550 ea (US); 900 ea (OUS) | Class II | Terminated | 16 Mar 2022 |
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 2022
- 839
- Share of these events in Class II
- 88%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 90
Other events of the firm
Official channels
- FDA enforcement report Z-0727-2022The 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.
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Cite this page
Recall Register. FDA enforcement event 89487. https://recallregister.com/fda/ii/89487/. 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:
US Nationwide distribution in the states of AZ, CA, FL, LA, MI, MO, MS, NC, NJ, OH, PA, TN, TX, and UT. The country of Canada.
- What quantity of product is in FDA event 89487?
- The FDA record gives this quantity:
15,550 ea (US); 900 ea (OUS)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 88% of the 839 device events that started in 2022 are in Class II.