Reported Jul 20, 2022 · Completed
Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE…
Ultradent Products, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ultradent Products, Inc. · 505 W 10200 S · South Jordan, UT · 84095-3800
Is this the product you have?
4 products · 17 lot codes
4541Peak Universal Bond Self-Etch Bottle Kit
- UDI-DI
00883205104274
3 recalled lot codes
BLRCRBM1Y7BM9G3
4554Peak Universal Bond Self-Etch Intro Kit
- UDI-DI
00883205104281
3 recalled lot codes
BLSGHBM578BN449
5135Peak SE Primer 4pk Refill
- UDI-DI
00883205104311
9 recalled lot codes
BLX3FBLSGMBLXSGBLXW4BM34MBM784BM9KBBMJVKBMTZM
S4554.Peak Universal Bond Sample SE, For use in light-curing dental bonding procedures.
- UDI-DI
00883205102065
2 recalled lot codes
BLRJJBM1NH
- Amount recalled
- 1331 Kits (5009 Syringes)
Where it was sold
Why it was recalled
SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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