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
Enforcement
- Recall Number
- Z-1816-2025
- Event ID
- 96779
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Baxter Healthcare Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 4, 2025
- Initiation Date
- May 6, 2025
- Classification Date
- May 23, 2025
- Address
- 1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States
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
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.
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
Worldwide distribution - US Nationwide and the countries of BAHRAIN, Canada, Chile, FRANCE, KUWAIT, NETHERLANDS, NORWAY, UNITED ARAB EMIRATES.
164 units