CLASS II ONGOING Device recall · Reported 4 Sep 2024 · FDA Enforcement Report
Medline procedure packs containing Shenli syringes recalled
Medline Industries LP - Northfield is recalling Medline procedure packs containing Shenli syringes, labeled as follows: Local Pack, pack. The recall was initiated on 8 Apr 2024 and the FDA has classified it as Class II.
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-2623-2024
- FDA event ID
- 94582
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Apr 2024
- FDA classified
- 28 Aug 2024
- Reported
- 4 Sep 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
- Syringes & Needles
Timeline
| 8 Apr 2024 | Recall initiated by company | |
| 28 Aug 2024 | Classified by FDA | +142 days |
| 4 Sep 2024 | Published in enforcement report | +7 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 packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack number DYNJ34129C, 2) FTMC LOCAL PACK-LF, pack number DYNJ54607A, 3) LOCAL PACK, pack number DYNJ61839B
Where it was distributed
Worldwide distribution.
Questions about this recall
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?
DYNJ34129C , Lot Number 21GBT130 , DYNJ34129C , Lot Number 21LBL623 , DYNJ34129C , Lot Number 22ABM033 , DYNJ34129C , Lot Number 22ABX499 , DYNJ34129C , Lot Number 19BBD954 , DYNJ34129C , Lot Number 19DBZ455 , DYNJ34129C , Lot Number 19EBU077 , DYNJ34129C , Lot Number 19GBU537 , DYNJ34129C , Lot Number 22IBG550 , DYNJ34129C , Lot Number 19JBN034 , DYNJ34129C , Lot Number 20BBF056 , DYNJ34129C , Lot Number 23FBG792 , DYNJ34129C , Lot Number 23GBE376 , DYNJ34129C , Lot Number 20FBS002 , DYNJ34129C , Lot Number 23JBR570 , DYNJ34129C , Lot Number 23JBY629 , DYNJ34129C , Lot Number 23KBU960 , DYNJ34129C , Lot Number 23KBW607 , DYNJ34129C , Lot Number 20KBW597 , DYNJ34129C , Lot Number 20LBM567 , DYNJ34129C , Lot Number 21EBA688 , DYNJ54607A , Lot Number 21HBS933 , DYNJ54607A , Lot Number 21JBH960 , DYNJ54607A , Lot Number 21JBZ002 , DYNJ54607A , Lot Number 21LBJ925 , DYNJ54607A , Lot Number 19BBP092 , DYNJ54607A , Lot Number 19CBB568 , DYNJ54607A , Lot Number 22GBH746 , DYNJ54607A , Lot Number 22GBZ352 , DYNJ54607A , Lot Number 19GBT320 , DYNJ54607A , Lot Number 22IBG226 , DYNJ54607A , Lot Number 19VBA464 , DYNJ54607A , Lot Number 19LBN255 , DYNJ54607A , Lot Number 23EBA098 , DYNJ54607A , Lot Number 20DBI269 , DYNJ54607A , Lot Number 20GBW370 , DYNJ54607A , Lot Number 21ABE502 , DYNJ54607A , Lot Number 21ABO952 , DYNJ54607A , Lot Number 21ABT074 , DYNJ61839B , Lot Number 21JBP698 , DYNJ61839B , Lot Number 21LBL729 , DYNJ61839B , Lot Number 22ABU420 , DYNJ61839B , Lot Number 22EBJ226 , DYNJ61839B , Lot Number 22HBA748 , DYNJ61839B , Lot Number 22IBR542 , DYNJ61839B , Lot Number 19IBN952 , DYNJ61839B , Lot Number 19LBT615 , DYNJ61839B , Lot Number 23EBD346 , DYNJ61839B , Lot Number 23GBE331 , DYNJ61839B , Lot Number 20DBD020 , DYNJ61839B , Lot Number 20GBV525 , DYNJ61839B , Lot Number 20JBC796 , DYNJ61839B , Lot Number 24ABV143 , DYNJ61839B , Lot Number 20KBZ290 , DYNJ61839B , Lot Number 21DBR237 , DYNJ61839B , Lot Number 21EBP718
Where was it sold?
Worldwide distribution.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 94582This product is part of a recall event; the main page for the event is Medline procedure packs containing Shenli syringes recalled.
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