Z-1816-2025 Class II Ongoing
FDA device recall Z-1816-2025 was initiated by Baxter Healthcare Corporation on May 6, 2025 and is designated Class II. Reason for recall: There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed. The recall status is ongoing. Affected quantity: 164 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 4, 2025
- Initiation Date
- May 6, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 164 units
Product Description
Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E100443, P3700E100444, P3700E100445, P3700E100446, P3700E100448, P3700E100449, P3700E100450, P3700E100453, P3700E100455, P3700E100456, P3700E100457, P3700E100459, P3700E100463, P3700E100468, P3700E100472, P3700E100476, and P3700E100477
Reason for Recall
There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of BAHRAIN, Canada, Chile, FRANCE, KUWAIT, NETHERLANDS, NORWAY, UNITED ARAB EMIRATES.
Code Information
UDI-DI: 00887761000896; 1) P3700E100429,Serial Number: A008AA9216; 2) P3700E100429,Serial Number: A008AA9217; 3) P3700E100429,Serial Number: A009AA9218; 4) P3700E100429,Serial Number: A009AA9219; 5) P3700E100429,Serial Number: A009AA9220; 6) P3700E100429,Serial Number: A031AA9361; 7) P3700E100429,Serial Number: A031AA9362; 8) P3700E100429,Serial Number: A042AA9428; 9) P3700E100429,Serial Number: Z352AA9154; 10) P3700E100429,Serial Number: Z352AA9155; 11) P3700E100429,Serial Number: Z353AA9169; 12) P3700E100429,Serial Number: Z354AA9172; 13) P3700E100429,Serial Number: Z354AA9173; 14) P3700E100429,Serial Number: Z354AA9175; 15) P3700E100429,Serial Number: Z354AA9177; 16) P3700E100432,Serial Number: A014AA9267; 17) P3700E100433,Serial Number: A008AA9214; 18) P3700E100433,Serial Number: A015AA9274; 19) P3700E100433,Serial Number: A015AA9285; 20) P3700E100433,Serial Number: A016AA9286; 21) P3700E100433,Serial Number: A016AA9287; 22) P3700E100433,Serial Number: Z358AA9187; 23) P3700E100434,Serial Number: Z345AA9079; 24) P3700E100434,Serial Number: Z345AA9080; 25) P3700E100434,Serial Number: Z345AA9081; 26) P3700E100434,Serial Number: Z346AA9088; 27) P3700E100434,Serial Number: Z346AA9089; 28) P3700E100434,Serial Number: Z346AA9090; 29) P3700E100434,Serial Number: Z346AA9091; 30) P3700E100434,Serial Number: Z346AA9098; 31) P3700E100434,Serial Number: Z347AA9112; 32) P3700E100434,Serial Number: Z348AA9120; 33) P3700E100434,Serial Number: Z348AA9121; 34) P3700E100434,Serial Number: Z348AA9122; 35) P3700E100434,Serial Number: Z348AA9123; 36) P3700E100434,Serial Number: Z348AA9124; 37) P3700E100434,Serial Number: Z348AA9125; 38) P3700E100435,Serial Number: A008AA9206; 39) P3700E100435,Serial Number: A009AA9222; 40) P3700E100435,Serial Number: A015AA9273; 41) P3700E100435,Serial Number: A034AA9371; 42) P3700E100435,Serial Number: A034AA9375; 43) P3700E100435,Serial Number: Z345AA9071; 44) P3700E100435,Serial Number: Z345AA9072; 45) P3700E100435,Serial Number: Z345AA9073; 46) P3700E100435,Serial Number: Z345AA9074; 47) P3700E100435,Serial Number: Z345AA9075; 48) P3700E100435,Serial Number: Z345AA9076; 49) P3700E100435,Serial Number: Z345AA9077; 50) P3700E100435,Serial Number: Z345AA9078; 51) P3700E100435,Serial Number: Z345AA9082; 52) P3700E100435,Serial Number: Z345AA9083; 53) P3700E100435,Serial Number: Z345AA9084; 54) P3700E100435,Serial Number: Z345AA9085; 55) P3700E100435,Serial Number: Z346AA9086; 56) P3700E100435,Serial Number: Z346AA9087; 57) P3700E100435,Serial Number: Z346AA9099; 58) P3700E100435,Serial Number: Z346AA9100; 59) P3700E100436,Serial Number: A008AA9207; 60) P3700E100436,Serial Number: A036AA9390; 61) P3700E100436,Serial Number: Z347AA9101; 62) P3700E100436,Serial Number: Z347AA9102; 63) P3700E100437,Serial Number: A035AA9388; 64) P3700E100437,Serial Number: A035AA9389; 65) P3700E100437,Serial Number: A036AA9392; 66) P3700E100437,Serial Number: A036AA9393; 67) P3700E100437,Serial Number: A036AA9394; 68) P3700E100437,Serial Number: A036AA9397; 69) P3700E100437,Serial Number: A036AA9398; 70) P3700E100437,Serial Number: A036AA9399; 71) P3700E100437,Serial Number: A036AA9400; 72) P3700E100437,Serial Number: A037AA9404; 73) P3700E100437,Serial Number: A037AA9410; 74) P3700E100437,Serial Number: A037AA9411; 75) P3700E100437,Serial Number: A037AA9412; 76) P3700E100437,Serial Number: A037AA9413; 77) P3700E100437,Serial Number: A041AA9421; 78) P3700E100437,Serial Number: A041AA9423; 79) P3700E100437,Serial Number: A041AA9425; 80) P3700E100438,Serial Number: A013AA9258; 81) P3700E100438,Serial Number: A013AA9259; 82) P3700E100438,Serial Number: A014AA9260; 83) P3700E100438,Serial Number: A014AA9261; 84) P3700E100438,Serial Number: A014AA9262; 85) P3700E100438,Serial Number: A031AA9359; 86) P3700E100438,Serial Number: A031AA9360; 87) P3700E100438,Serial Number: A031AA9363; 88) P3700E100439,Serial Number: Z353AA9165; 89) P3700E100441,Serial Number: A014AA9271; 90) P3700E100441,Serial Number: A014AA9272; 91) P3700E100441,Serial Number: Z346AA9092; 92) P3700E100441,Serial Number: Z346AA9093; 93) P3700E100442,Serial Number: A037AA9405; 94) P3700E100442,Serial Number: A041AA9416; 95) P3700E100442,Serial Number: A041AA9417; 96) P3700E100442,Serial Number: Z354AA9174; 97) P3700E100443,Serial Number: Z352AA9157; 98) P3700E100443,Serial Number: Z353AA9158; 99) P3700E100443,Serial Number: Z353AA9159; 100) P3700E100443,Serial Number: Z353AA9161; 101) P3700E100444,Serial Number: Z346AA9094; 102) P3700E100444,Serial Number: Z346AA9095; 103) P3700E100445,Serial Number: Z347AA9113; 104) P3700E100445,Serial Number: Z347AA9114; 105) P3700E100445,Serial Number: Z347AA9115; 106) P3700E100446,Serial Number: A034AA9370; 107) P3700E100446,Serial Number: Z352AA9144; 108) P3700E100446,Serial Number: Z352AA9148; 109) P3700E100446,Serial Number: Z352AA9149; 110) P3700E100446,Serial Number: Z352AA9150; 111) P3700E100446,Serial Number: Z353AA9166; 112) P3700E100446,Serial Number: Z353AA9167; 113) P3700E100446,Serial Number: Z354AA9176; 114) P3700E100448,Serial Number: A035AA9386; 115) P3700E100448,Serial Number: Z346AA9096; 116) P3700E100449,Serial Number: Z348AA9116; 117) P3700E100449,Serial Number: Z348AA9117; 118) P3700E100449,Serial Number: Z348AA9118; 119) P3700E100449,Serial Number: Z348AA9119; 120) P3700E100450,Serial Number: Z351AA9130; 121) P3700E100453,Serial Number: Z347AA9104; 122) P3700E100453,Serial Number: Z347AA9105; 123) P3700E100453,Serial Number: Z347AA9106; 124) P3700E100453,Serial Number: Z347AA9109; 125) P3700E100455,Serial Number: Z351AA9135; 126) P3700E100455,Serial Number: Z351AA9136; 127) P3700E100455,Serial Number: Z351AA9137; 128) P3700E100456,Serial Number: Z347AA9103; 129) P3700E100456,Serial Number: Z347AA9107; 130) P3700E100456,Serial Number: Z347AA9108; 131) P3700E100456,Serial Number: Z353AA9168; 132) P3700E100457,Serial Number: Z347AA9110; 133) P3700E100457,Serial Number: Z347AA9111; 134) P3700E100459,Serial Number: Z354AA9178; 135) P3700E100459,Serial Number: Z355AA9179; 136) P3700E100459,Serial Number: Z355AA9180; 137) P3700E100463,Serial Number: Z346AA9097; 138) P3700E100468,Serial Number: A010AA9245; 139) P3700E100468,Serial Number: A013AA9246; 140) P3700E100468,Serial Number: A013AA9247; 141) P3700E100468,Serial Number: A016AA9295; 142) P3700E100468,Serial Number: A016AA9296; 143) P3700E100468,Serial Number: A016AA9298; 144) P3700E100468,Serial Number: A027AA9305; 145) P3700E100468,Serial Number: A035AA9382; 146) P3700E100472,Serial Number: A031AA9357; 147) P3700E100472,Serial Number: A031AA9358; 148) P3700E100476,Serial Number: A031AA9355; 149) P3700E100476,Serial Number: A031AA9356; 150) P3700E100476,Serial Number: A035AA9378; 151) P3700E100476,Serial Number: A035AA9379; 152) P3700E100476,Serial Number: A035AA9380; 153) P3700E100476,Serial Number: A035AA9383; 154) P3700E100476,Serial Number: A035AA9387; 155) P3700E100476,Serial Number: A036AA9402; 156) P3700E100476,Serial Number: A037AA9406; 157) P3700E100476,Serial Number: A037AA9408; 158) P3700E100476,Serial Number: A037AA9414; 159) P3700E100476,Serial Number: A037AA9415; 160) P3700E100477,Serial Number: A042AA9433; 161) P3700E100477,Serial Number: A042AA9435; 162) P3700E100477,Serial Number: A042AA9436; 163) P3700E100477,Serial Number: A042AA9437; 164) P3700E100477,Serial Number: A042AA9438