CLASS II Device recall · Reported 16 Aug 2017 · FDA Enforcement Report
Piston Syringe, 3 CC L/L recalled by International Medsurg
International Medsurg Connection is recalling Piston Syringe, 3 CC L/L, 100 per, 30 boxes/case The products are used to inject fluids, distributed nationwide in the US. The recall was initiated on 23 Jun 2017 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-2851-2017
- FDA event ID
- 77658
- Recalling firm
- International Medsurg Connection, Schaumburg, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Jun 2017
- FDA classified
- 4 Aug 2017
- Reported
- 16 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Syringes & Needles
Timeline
| 23 Jun 2017 | Recall initiated by company | |
| 4 Aug 2017 | Classified by FDA | +42 days |
| 16 Aug 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Insufficient documentation to support product sterility claims.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Piston Syringe, 3 CC L/L, 100 per box, 30 boxes/case, 3,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Where it was distributed
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
Nationwide AlaskaAlabamaCaliforniaFloridaGeorgiaIllinoisIndianaKansasLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiNorth CarolinaNebraskaNew JerseyNew YorkPennsylvania
Questions about this recall
Is Piston Syringe, 3 CC L/L, 100 per, 30 boxes/case The products are used to inject fluids recalled?
Yes. International Medsurg Connection recalled Piston Syringe, 3 CC L/L, 100 per, 30 boxes/case The products are used to inject fluids on 23 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-2851-2017.
Why was it recalled?
Insufficient documentation to support product sterility claims.
Which lots are affected?
Catalog No. SY35003LL. Known Lot No. ("x" represents any release number): 12-6780-x, 12-6925-x, 12-6968-x, 12-7060-x, 12-7119-x, 12-7144-x, 12-7177-x, 12-7208-x, 12-7258-x, 12-7259-x, 12-7324-x, 12-7325-x, 12-7363-x, 12-7391-x, 12-7412-x, 12-7463-x, 12-7469-x, 12-7472-x, 12-7499-x, 13-6780-x, 13-7538-x, 13-7560-x, 13-7581-x, 13-7648-x, 13-7667-x, 13-7702-x, 13-7704-x, 13-7719-x, 13-7733-x, 13-7761-x, 13-7841-x, 13-7920-x, 13-7950-x, 13-7966-x, 13-7988-x, 13-8006-x, 13-8032-x, 13-8039-x, 13-8082-x, 13-8083-x, 13-8084-x, 13-8143-x, 13-8144-x, 13-8145-x, 13-8149-x, 13-8184-x, 13-8185-x, 13-8489-x, 13-8272-x, 14-8327-x, 14-8335-x, 14-8354-x, 14-8385-x, 14-8386-x, 14-8396-x, 14-8440-x, 14-8441-x, 14-8442-x, 14-8457-x, 14-8509-x, 14-8512-x, 14-8513-x, 14-8540-x, 14-8541-x, 14-8542-x, 14-8583-x, 14-8628-x, 14-8631-x, 14-8696-x, 14-8737-x, 14-8794-x, 14-8807-x, 14-8829-x, 14-8863-x, 14-9851-x, 14-9015-x, 14-9035-x, 14-9064-x, 14-9081-x, 15-0113-x, 15-9333-x, 15-9350-x, 15-9351-x, 15-9364-x, 15-9377-x, 15-9442-x, 15-9447-x, 15-9492-x, 15-9550-x, 15-9587-x, 15-9605-x, 15-9630-x, 15-9638-x, 15-9639-x, 15-9716-x, 15-9723-x, 15-9759-x, 15-9797-x, 15-9805-x, 15-9860-x, 15-9873-x, 15-9876-x, 15-9963-x, 16-0366-x, 16-0399-x, 16-0439-x, 16-0441-x, 16-0473-x, 16-0527-x, 16-0624-x, 16-0632-x, 16-0655-x, 16-0736-x, 16-0783-x, 16-0839-x, 16-0904-x, 16-0969-x, 16-1005-x, 16-1023-x, 16-1040-x, 16-1053-x, 16-1054-x, 16-1055-x, 16-1079-x, 16-1101-x, 16-1102-x, 16-1153-x, 16-1165-x, 17-1443-x, 17-1492-x, 17-1527-x, 17-1535-x, 17-1557-x, 17-1562-x, 17-1575-x, 17-1609-x, 17-1613-x, 17-1617-x, 17-1624-x, 17-1637-x, 17-1691-x, 17-1715-x, 17-1791-x.
Where was it sold?
Nationwide Distribution including OH, MA, GA, FL, NC, MS, MO, PA, IN, NJ, TX, KS, LA, NE, WA, AL, UT, AK, CA, IL, MN, MD, NY, and MI.
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 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.
More recalls from International Medsurg Connection
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|---|---|---|---|---|---|
| Device | CLASS II | Hypodermic Needle REG Bevel recalled by International Medsurg | International Medsurg Connection | Sterility | Nationwide |
| Device | CLASS II | Hypodermic Needle REG Bevel recalled by International Medsurg | International Medsurg Connection | Sterility | Nationwide |
| Device | CLASS II | Piston Syringe, 20 CC L/S recalled by International Medsurg | International Medsurg Connection | Sterility | Nationwide |
| Device | CLASS II | Hypodermic Needle REG Bevel recalled by International Medsurg | International Medsurg Connection | Sterility | Nationwide |
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