CareFusion 213, LLC BD ChloraPrep Clear Recall
Announced 2026-07-22 · FDA
The FDA is recalling CareFusion 213, LLC's BD ChloraPrep Clear 60 x 1 mL applicators due to a lack of assurance of sterility from an open or incomplete seal on the packaging. About 43,066,599 units were distributed nationwide, with many lot numbers and expirations through 2029.
| Brand | CareFusion 213, LLC |
|---|---|
| Product | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31 |
| Reason | Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator |
| Severity | moderate |
| Units affected | 43066599 |
| Distribution | U.S.A. Nationwide |
| Agency | FDA |
| Recall / campaign no. | Lots: 4062535, 4065201, 4066446, Exp. 2/28/2027; 4141090, Exp. 5/31/2027; 4180288, 4197695, 4197697, 4180291, Exp. 6/30/2027; 4219454, 4221945, 4221966, 4222853, 4224361, Exp. 7/31/2027; 4228482, 4248656, 4249026, 4248961, 4249818, 4250729, Exp. 8/31/2027; 5124984, 5127231, 5129058, 5126398, 5129488, Exp. 4/30/2028; 5130576, 5142947, 5147432, 5154673, 5154671, 5156442, 5157968, 5158031, 5150160, 5155824, Exp. 5/31/2028; 5176326, 5181676, 5181074, 5182660, 5188102, 5188103, Exp. 6/30/2028; 5195818, 5199118, 5209474, 5210853, 5211985, 5211907, 5211212, Exp. 7/31/2028; 5226576, 5227151, 5230531, 5241733, 5242057, 5243430, 5246952, 5248375, 5248189, Exp. 8/31/2028; 5254509, 5274692, 5276968, 5279226, 5280240, Exp. 9/30/2028; 5305661, 5307185, 5309623, 5310701, Exp. 10/31/2028; 5346128, 5350797, Exp. 12/31/2028; 6031034, 6031234, 6037918, Exp. 1/31/2029; 6051588, 6054213, 6062168, 6063361, Exp. 2/28/2029; 6069891, Exp. 3/31/2029; 6111107, Exp. 4/30/2029. |
WHAT YOU SHOULD DO
- Do not use recalled units; identify if your product matches listed lots or expirations.
- Set aside recalled product and contact the supplier or distributor for disposal, replacement, or refund.
- If you are in a healthcare setting, follow your institution's recall procedures.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.