CLASS I ONGOING Device recall · Reported 14 Aug 2024 · FDA Enforcement Report
Medline procedure kits labeled as: Nephrology Pack, Pack Number recalled
MEDLINE INDUSTRIES, LP - Northfield is recalling Medline procedure kits labeled as: Nephrology Pack, Pack Number, distributed nationwide in the US. The recall was initiated on 8 Apr 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2443-2024
- FDA event ID
- 94580
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 8 Apr 2024
- FDA classified
- 8 Aug 2024
- Reported
- 14 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 8 Apr 2024 | Recall initiated by company | |
| 8 Aug 2024 | Classified by FDA | +122 days |
| 14 Aug 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, Pack Number DYNJRA1221A
Where it was distributed
Worldwide Distribution: US (nationwide) and OUS countries of: AE, AI, BB, CA, CL, CY, DE, GT, HN, JP, MX, MY, PA, PE, PR, SA, SG, TC, TT, VI, PR, TT, MX, BM, ES, NI, DO, GU, CR, AT, CD, DE, DF, W, and ON.
Questions about this recall
Is Medline procedure kits labeled as: Nephrology Pack, Pack Number recalled?
Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline procedure kits labeled as: Nephrology Pack, Pack Number on 8 Apr 2024. The recall is Class I and its status is Ongoing. Recall number Z-2443-2024.
Why was it recalled?
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Which lots are affected?
DYNJ59089 , Lot Number 23IBF074 ; DYNJRA1221A , Lot Number 20IDB255 ; DYNJRA1221A , Lot Number 22BDA978 ; DYNJRA1221A , Lot Number 22KDA950 ; DYNJRA1221A , Lot Number 22LDA146 ; DYNJRA1221A , Lot Number 23ADB422 ; DYNJRA1221A , Lot Number 23BDB453 ; DYNJRA1221A , Lot Number 23IDA424 ; DYNJRA1221A , Lot Number 23JDB010
Where was it sold?
Worldwide Distribution: US (nationwide) and OUS countries of: AE, AI, BB, CA, CL, CY, DE, GT, HN, JP, MX, MY, PA, PE, PR, SA, SG, TC, TT, VI, PR, TT, MX, BM, ES, NI, DO, GU, CR, AT, CD, DE, DF, W, and ON.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS I | Medline medical convenience kits labeled as recalled | MEDLINE INDUSTRIES, LP - Northfield | Device Malfunction | 6 states |
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