Device recall: Surgicare Neuro Pack - Neurological Kit
Class II FDA enforcement event 89671. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
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
Stradis Medical, LLC dba Stradis Healthcare started this device recall on 25 Feb 2022. The firm address in the FDA record is in Peachtree Corners, GA. FDA put the recall in Class II. FDA event 89671 has 5 product records. The first FDA enforcement report date is 13 Apr 2022. 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.
US Nationwide distribution in the states of IN, TX, and PA.
Recalling firm
Stradis Medical, LLC dba Stradis Healthcare, Peachtree Corners, GA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
5 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0862-2022 | Surgicare Neuro Pack - Neurological Kit | 176 units | Class II | Ongoing | 13 Apr 2022 |
| Z-0863-2022 | Lum Lam Custom Pack - Anesthesia Kit | 21 units | Class II | Ongoing | 13 Apr 2022 |
| Z-0864-2022 | Total Knee Pack - Surgical Kit | 76 units | Class II | Ongoing | 13 Apr 2022 |
| Z-0865-2022 | Anterior Hip Pack - Surgical Kit | 100 units | Class II | Ongoing | 13 Apr 2022 |
| Z-0866-2022 | Coryell Memorial Hosp Total, Joint Pack - Surgical Kit | 348 units | Class II | Ongoing | 13 Apr 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
- 5Median of the firm: 5
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 Nov 2022 | STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431 | Device | Class II | 78 |
| 25 Jul 2022 | NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697 | Device | Class II | 3 |
| 28 Oct 2021 | Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk | Device | Class II | 1 |
| 10 Sep 2021 | Tenaculum, Plastic | Device | Class II | 6 |
Official channels
- FDA enforcement report Z-0862-2022The 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 89671. https://recallregister.com/fda/ii/89671/. 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 IN, TX, and PA.
- What quantity of product is in FDA event 89671?
- The event has 5 product records. The first record gives this quantity:
176 units
- 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.