CLASS I ONGOING Device recall · Reported 17 Jul 2024 · FDA Enforcement Report
Bausch+Lomb, I-pack Injection Kit recalled by Synergetics
Synergetics is recalling Bausch+Lomb, I-pack Injection Kit, distributed nationwide in the US. The recall was initiated on 12 Jun 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-2251-2024
- FDA event ID
- 94793
- Recalling firm
- Synergetics, O Fallon, MO
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 12 Jun 2024
- FDA classified
- 11 Jul 2024
- Reported
- 17 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 12 Jun 2024 | Recall initiated by company | |
| 11 Jul 2024 | Classified by FDA | +29 days |
| 17 Jul 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
Sterilization certificates could not be validated by the supplier
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
BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
Sterilization certificates could not be validated by the supplier
Which lots are affected?
UDI/DI 20841305107544, Lot Number P62764979R
Where was it sold?
US Nationwide
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 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
3 other products · FDA event 94793| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Bausch+Lomb, I-pack Injection Kit with Drape recalled by Synergetics | Synergetics | Sterility | Nationwide | |
| CLASS I | Bausch+Lomb, I-pack Injection Kit with Wire Speculum recalled | Synergetics | Sterility | Nationwide | |
| CLASS I | Bausch+Lomb, I-pack Injection Kit Custom recalled by Synergetics | Synergetics | Sterility | Nationwide |
More recalls from Synergetics
All 37| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bausch+Lomb, I-pack Injection Kit Custom recalled by Synergetics | Synergetics | Sterility | Nationwide |
| Device | CLASS I | Bausch+Lomb, I-pack Injection Kit with Wire Speculum recalled | Synergetics | Sterility | Nationwide |
| Device | CLASS I | Bausch+Lomb, I-pack Injection Kit with Drape recalled by Synergetics | Synergetics | Sterility | Nationwide |
| Device | CLASS II | VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product recalled | Synergetics | Packaging Defects | 14 states |
| Device | CLASS II | VersaVit 2.0 Vitrectomy Cutter, Product recalled by Synergetics | Synergetics | Packaging Defects | 14 states |
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