CareFusion 213, LLC: BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Ste

Company / brand

CareFusion 213, LLC

Product

BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.

Reason / hazard

Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

Classification

Class II

Status

Ongoing

Distribution / sold at

Nationwide inthe USA, as well as other foreign distribution.

Recall initiated

2026-05-28

Code info

Lot # 3143780, 3151595, 3152898, 3152906, 3157235, 3158139, 3159803, 3166919, 3167620, 3191056, Exp Date: 05/31/2026; Lot # 3171115, 3172853, 3177820, 3193968, 3194750, 3199123, 3201195, 3206618, 3212202, 3213819, 3214876, Exp Date: 06/30/2026; Lot # 3222170, 3226846, 3228153, 3229867, 3228293, 3243337, Exp Date: 07/31/2026; Lot # 3230424, 3234042, 3240990, 3244469, 3249346, 3251278, 3254346, 3255678, 3258407, Exp Date: 08/31/2026; Lot # 3261058, 3263492, 3264573, 3268341, 3270418, 3275533, 3276460, 3278683, 3283037, 3284107, 3292960, 3292965, Exp Date: 09/30/2026; Lot # 3286221, 3290240, 3293922, 3297295, 3298930, 3299555, 3299562, 3301403, 3304245, 3306751, 3307190, 3310919, 3310926, 3314371, Exp Date: 10/31/2026; Lot # 3319520, 3321408, 3321409, 3324363, 3324369, 3332082, 3334305, 3335243, 3336896, 3337416, 3337417, 3340134, 3343540, 3346461, Exp Date: 11/30/2026; Lot # 3347121, 3350902, 3353143, 4004043, 4008394, 4009336, 4011488, 4012213, Exp Date: 12/31/2026; Lot # 4017668, 4019659, 4024538, 4025597, 4028103, 4030830, 4031885, 4032130, 4034194, 4037955, 4039988, 4039341, 4042520, 4045073, Exp Date: 01/31/2027; Lot # 4045127, 4050288, 4053896, 4058398, 4060624, 4062561, 4066133, 4068918, 4070112, 4074981, 4075814, 4078276, Exp Date: 02/28/2027; Lot # 4072390, 4073005, 4079088, 4080879, 4081625, 4086628, 4087806, 4096981, 4100347, 4100349, 4103385, 4103386, 4110975, 4113747, 4131843, Exp Date: 03/31/2027; Lot # 4121050, 4123171, 4123172, 4128501, 4128502, 4130512, 4135272, Exp Date: 04/30/2027; Lot # 4141597, 4150024, 4149611, 4150025, 4152202, 4157691, 4159978, 4160566, 4163121, Exp Date: 05/31/2027; Lot # 4173445, 4173447, 4178299, 4178303, 4180764, 4193574, 4197392, 4200111, 4204425, Exp Date: 06/30/2027; Lot # 4205156, 4206764, 4206766, 4207230, 4213335, 4211319, 4215668, 4218795, 4220980, 4242090, Exp Date: 07/31/2027; Lot # 4226396, 4227235, 4229934, 4232786, 4236636, 4236982, 4236489, 4242092, 4242505, 4248359, 4250795, 4254763, Exp Date: 08/31/2027; Lot # 4256132, 4260191, 4261289, 4261760, 4262812, 4269519, 4270776, 4271977, 4274445, 4276054, 4282861, Exp Date: 09/30/2027; Lot # 4284334, 4290362, 4291615, 4297871, 4299657, 4300686, 4302997, 4303204, 4305323, 4305318, 4310195, 4311615, 4312855, 4313930, Exp Date: 10/31/2027.

Product quantity

N/A

Voluntary mandated

Voluntary: Firm initiated

City

El Paso

State

TX

Country

United States

Event id

99114

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