CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic.
Cardinal Health 200, LLC · Potential contamination of the product with latex adhesive residual.
Open FDA's page for this record- Cfres ID
- 207175
- Product res number
- Z-1835-2024
- Event date initiated
- 2024-04-17
- Event date posted
- 2024-05-16
- Recall status
- Open, Classified
- Res event number
- 94407
- Product code
- KGX
- Product description
- CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic.
- Code info
- Lot #A14722, UDI-DI: 50192253049907 (CS), 20192253049906 (BX)
- Firm FEI number
- 3001236905
- Recalling firm
- Cardinal Health 200, LLC
- Address 1
- 3651 Birchwood Dr
- City
- Waukegan
- State
- IL
- Postal code
- 60085-8337
- Additional info contact
- 847-887-5500
- Reason for recall
- Potential contamination of the product with latex adhesive residual.
- Root cause description
- Under Investigation by firm
- Product quantity
- 2,000 packages
- Distribution pattern
- US Nationwide distribution.
- Action
On 4/17/2024, the recalling firm issued letters dated 4/17/2024 via overnight mail explaining the reason for recall, the risk to health, and the required actions, which were: (1) Review inventory for the affected product code and lot number; (2) communicate with all personnel that utilize the product; (3) segregate and quarantine all affected product and utilize the return directions in the letter; (4) disseminate the notice to all departments, clinics, and external campuses that handle the affected product; (5) distributors are to notify any customers to whom they may have distributed/forwarded the affected product to or plan to send the product; (6) return the enclosed acknowledgment form via FAX or email whether or not the consignee has the product. The letter contained the various phone numbers for the Customer Service groups (hospital, federal government, distributor, and all other customers) to arrange for return of the product and for questions related to the recall. An attachment was enclosed with the letter to show an example of where the lot number can be located on the label.
- Harmonized identifiers (openFDA)
- Device name
- Tape And Bandage, Adhesive
- Medical specialty description
- General Hospital
- Regulation number
- 880.5240
- Device class
- 1
- K number
- K841897, K896733, K813361, K802764, K923319, K883660, K802242, K941788, K840609, K811291, K935948, K843873, K923300, K894274, K870900, K944588, K912160, K853647, K884108, K802795, K905022, K870093, K895920, K872593, K942383, K842946, K930457, K912550, K840951, K921759, K792102, K926264, K810053, K880964, K810050, K941379, K912623, K791885, K925384, K932602 +147 more
- Registration number
- 3017231740, 3006554788, 3005630901, 1030451, 3004111573, 3042277868, 3045076483, 2214133, 3032911850, 8044116, 3004950768, 3031743608, 3023809973, 3011191255, 3024088964, 3010398913, 3009349165, 3016872092, 3008174904, 3013525506, 3016159364, 3017448136, 3017672584, 3014368824, 1226711, 3013473968, 2135339, 1836161, 3031841433, 3007048057, 3043740372, 3010380518, 1450662, 3025440611, 3005024024, 9611024, 3006260740, 9680271, 3014656668, 3005941719 +965 more
- FEI number
- 3003338236, 3017231740, 3006554788, 3005630901, 1030451, 3004111573, 3042277868, 3045076483, 3002807038, 2214133, 3032911850, 1000220650, 3004950768, 3031743608, 3023809973, 3011191255, 3024088964, 3003753482, 3010398913, 3009349165, 3016872092, 3008174904, 3013525506, 3016159364, 3017448136, 3017672584, 3003191258, 3030824101, 1000306431, 3014368824, 3013473968, 3004574120, 1000112877, 1000123297, 3031841433, 3007048057, 3011774813, 3043740372, 3041329419, 3006076154 +965 more
